Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-01-01 @ 1:24 AM
Study NCT ID:
NCT04661033
Status:
TERMINATED
Last Update Posted:
2024-12-05
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Hungary'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599209', 'term': 'isatuximab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610 ext 6#', 'title': 'Trial Transparency Team', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}}, 'adverseEventsModule': {'timeFrame': 'TEAEs were collected from first dose of study drug (Day 1) up to 30 days after last study intervention administration, approximately 101 days. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to end of study, approximately 169 days.', 'description': 'Analysis was performed on safety population. The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Liver Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) And Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug (Day 1) up to 30 days after last study intervention administration, approximately 101 days', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred from the time of the first IMP administration up to 30 days (included) after the last IMP administration. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants exposed to the IMP (regardless of the amount of treatment administered).'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants With Potentially Clinically Significant Abnormality (PCSA): Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Hb: ≤ 115 g/L (M); ≤ 95 g/L (F)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hb: ≥ 185 g/L (M); ≥ 165 g/L (F),', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hb: Decrease from baseline ≥ 20 g/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit: ≤ 0.37 v/v (M); ≤ 0.32 v/v (F)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit: ≥ 0.55 v/v (M); ≥ 0.5 v/v (F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Erythrocyte Count: ≥ 6 x 10^12/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count: < 100 x 10^9/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count: ≥ 700 x 10^9/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes: < 3 x 10^9/L (NB); < 2 x 10^9/L (B)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes: ≥ 16 x 10^9/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils: < 1.5 x 10^9/L (NB); < 1 x 10^9/L (B)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes: > 4 x 10^9/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes: > 0.7 x 10^9/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Basophils: > 0.1 x 10^9/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils: > 0.5 x 10^9/L or > ULN (if ULN ≥ 0.5 x 10^9/L)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were collected to determine the hematology laboratory significant abnormalities. PCSA values: abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Hemoglobin (Hb): ≤ 115 grams per Liter (g/L) (Male\\[M\\]); ≤ 95 g/L (Female\\[F\\]), ≥ 185 g/L (M); ≥ 165 g/L (F), Decrease from baseline ≥ 20 g/L; Hematocrit: ≤ 0.37 volume per volume (v/v) (M); ≤ 0.32 v/v (F), ≥ 0.55 v/v (M); ≥ 0.5 v/v (F); Erythrocyte Count: ≥ 6 x 10\\^12 per Liter (/L); Platelet count: \\< 100 x 10\\^9/L, ≥ 700 x 10\\^9/L; Leukocytes: \\< 3 x 10\\^9/L (Non-Black \\[NB\\]); \\< 2 x 10\\^9/L (Black \\[B\\]), ≥ 16 x 10\\^9/L; Neutrophils: \\< 1.5 x 10\\^9/L (B); \\< 1 x 10\\^9/L (B); Lymphocytes: \\> 4 x 10\\^9/L; Monocytes: \\> 0.7 x 10\\^9/L; Basophils: \\> 0.1 x 10\\^9/L; Eosinophils: \\> 0.5 x 10\\^9/L or \\> Upper limit of Normal (ULN) (if ULN ≥ 0.5 x 10\\^9/L).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants exposed to the IMP (regardless of the amount of treatment administered).'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants With PCSA: Clinical Chemistry And Electrolyte Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Glucose: ≤ 3.9 mmol/L and < LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Glucose: ≥ 11.1 mmol/L (unfasted); ≥ 7 mmol/L (fasted)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine: ≥ 150 µmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine: ≥ 30% change from baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine: ≥ 100% change from baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT: > 3 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT: > 5 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT: > 10 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST: > 3 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALP: > 1.5 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin: > 1.5 ULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin: > 2 ULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Sodium: ≤ 129 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium: ≥ 160 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Potassium: < 3 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Potassium: ≥ 5.5 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were collected to determine the clinical chemistry laboratory and electrolyte parameters significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Glucose: ≤ 3.9 millimoles per Liter (mmol/L) and \\< Lower limit of normal (LLN), ≥ 11.1 mmol/L (unfasted); ≥ 7 mmol/L (fasted); Creatinine: ≥ 150 micromoles (µmol)/L, ≥ 30% change from baseline, ≥ 100% change from baseline, Alanine Aminotransferase (ALT): \\> 3 ULN, \\> 5 ULN, \\> 10 ULN; Aspartate Aminotransferase (AST): \\> 3 ULN; Alkaline Phosphatase (ALP): \\> 1.5 ULN; Total Bilirubin: \\> 1.5 ULN, \\> 2 ULN; Sodium: ≤ 129 mmol/L, ≥ 160 mmol/L and Potassium: \\< 3 mmol/L, ≥ 5.5 mmol/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants exposed to the IMP (regardless of the amount of treatment administered).'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants With Potentially Clinically Significant Abnormality: Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'pH: ≤ 4.6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'pH: ≥ 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Urine samples were collected to determine the urinalysis parameter significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: pH: ≤ 4.6 or ≥ 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants exposed to the IMP (regardless of the amount of treatment administered).'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants With Potentially Clinically Significant Abnormality: Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'SSBP: ≤95 mmHg and decrease from baseline ≥20 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'SSBP: ≥160 mmHg and increase from baseline ≥20 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SDBP: ≤45 mmHg and decrease from baseline ≥10 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'SDBP: ≥ 110 mmHg and increase from baseline ≥ 10 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SHR: ≤ 50 bpm and decrease from baseline ≥ 20 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SHR: ≥ 120 bpm and increase from baseline ≥ 20 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Weight: ≥5% decrease from baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight: ≥ 5% increase from baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Vital signs were examined to determine the abnormalities. Vital signs included Sitting systolic blood pressure (SSBP), Sitting diastolic blood pressure (SDBP), Sitting heart rate (SHR) and weight. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: SSBP: ≤95 millimeters of mercury (mmHg) and decrease from baseline ≥20 mmHg; ≥160 mmHg and increase from baseline ≥20 mmHg; SDBP: ≤45 mmHg and decrease from baseline ≥10 mmHg, ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; SHR: ≤ 50 beats per minute (bpm) and decrease from baseline ≥ 20 bpm, ≥120 bpm and increase from baseline ≥ 20 bpm; Weight: ≥ 5% decrease from baseline, ≥5% increase from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants exposed to the IMP (regardless of the amount of treatment administered).'}, {'type': 'PRIMARY', 'title': 'Part B: Overall Response Rate (Response [R] Or Complete Response [CR]) At Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Day 85', 'description': 'Overall response rate was defined as the percentage of participants with a response (R) or complete response (CR) over the evaluable participants. R was defined as an increase in Hb by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis might still be present. CR was defined as Hb ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, Lactate dehydrogenase \\[LDH\\], haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part A: Cohorts 2 and 3: Overall Response Rate (Response [R] Or Complete Response [CR]) At Day 85 And Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Day 85', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 85 and Day 169', 'description': 'Overall response rate was defined as the percentage of participants with a R or CR over the evaluable participants. R was defined as an increase in Hb by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis might still be present. CR was defined as Hb ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, LDH, haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants exposed to the IMP (regardless of the amount of treatment administered).'}, {'type': 'SECONDARY', 'title': 'Part A: Cohorts 2 and 3: Percentage Of Participants With Durable Hemoglobin (Hb) Response By Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study (Day 169)', 'description': 'Durable response was defined as Hb level ≥10 g/dL with an increase from baseline of ≥2 g/dL on three consecutive evaluable visits during the study period; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants exposed to the IMP (regardless of the amount of treatment administered).'}, {'type': 'SECONDARY', 'title': 'Part A: Cohorts 2 and 3: Absolute Change From Baseline in Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Scale Score At Day 85 and Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '12.0', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 85 and Day 169', 'description': 'The FACIT-Fatigue scale is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0 to 4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52, where higher score (and positive change scores) indicated better functioning. Baseline was defined as the Day 1 pre-dose value.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants exposed to the IMP (regardless of the amount of treatment administered). Only those participants with data collected at each specified timepoint are reported.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Baseline In Lactate Dehydrogenase (LDH) at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Pre-dose at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.0', 'spread': '347.5', 'groupId': 'OG000'}, {'value': '-67.3', 'spread': '81.4', 'groupId': 'OG001'}, {'value': '-264.0', 'spread': '196.6', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '192.3', 'groupId': 'OG000'}, {'value': '-110.7', 'spread': '126.5', 'groupId': 'OG001'}, {'value': '-331.5', 'spread': '236.9', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-342.3', 'spread': '130.2', 'groupId': 'OG000'}, {'value': '-124.0', 'spread': '133.3', 'groupId': 'OG001'}, {'value': '-234.5', 'spread': '105.4', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-355.5', 'spread': '444.8', 'groupId': 'OG000'}, {'value': '-136.0', 'spread': '349.9', 'groupId': 'OG001'}, {'value': '-309.5', 'spread': '231.2', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-134.0', 'spread': '183.8', 'groupId': 'OG000'}, {'value': '-22.0', 'spread': '201.8', 'groupId': 'OG001'}, {'value': '-146.0', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '278.7', 'spread': '601.0', 'groupId': 'OG001'}, {'value': '-135.0', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: LDH. Baseline is defined as the last assessment value before IMP.', 'unitOfMeasure': 'International Units per Liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants exposed to the IMP (regardless of the amount of treatment administered). Only those participants with data collected at each specified timepoint are reported.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Baseline In Haptoglobin at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Pre-dose at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.030', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '-0.005', 'spread': '0.007', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-0.010', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-0.016', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '-0.005', 'spread': '0.007', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-0.025', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '2.995', 'spread': '4.250', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-0.025', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '-0.010', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.022', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '-0.050', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: Haptoglobin. Baseline was defined as the last assessment value before IMP.', 'unitOfMeasure': 'Grams per Liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants exposed to the IMP (regardless of the amount of treatment administered). Only those participants with data collected at each specified timepoint are reported.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Baseline In Reticulocytes at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Pre-dose at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.000', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-25.533', 'spread': '49.878', 'groupId': 'OG001'}, {'value': '-158.400', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.000', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-29.733', 'spread': '36.258', 'groupId': 'OG001'}, {'value': '-347.400', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-51.000', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-36.833', 'spread': '34.662', 'groupId': 'OG001'}, {'value': '-370.300', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.000', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-31.733', 'spread': '84.835', 'groupId': 'OG001'}, {'value': '-280.300', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.000', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-6.133', 'spread': '33.198', 'groupId': 'OG001'}, {'value': '-250.600', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-126.933', 'spread': '70.273', 'groupId': 'OG001'}, {'value': '9.900', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: Reticulocytes. Baseline was defined as the last assessment value before IMP.', 'unitOfMeasure': '10^9 cells per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants exposed to the IMP (regardless of the amount of treatment administered). Only those participants with data collected at each specified timepoint are reported.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Baseline In Total Bilirubin at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Pre-dose at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.52', 'spread': '19.00', 'groupId': 'OG000'}, {'value': '-7.01', 'spread': '3.12', 'groupId': 'OG001'}, {'value': '-15.00', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '15.88', 'groupId': 'OG000'}, {'value': '-6.38', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '-13.00', 'spread': '4.24', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-18.26', 'spread': '31.86', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '-8.50', 'spread': '7.78', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.31', 'spread': '5.89', 'groupId': 'OG000'}, {'value': '-8.21', 'spread': '17.53', 'groupId': 'OG001'}, {'value': '-14.50', 'spread': '10.61', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '18.47', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '11.83', 'groupId': 'OG001'}, {'value': '-4.00', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '9.08', 'groupId': 'OG001'}, {'value': '17.00', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: Total Bilirubin. Baseline was defined as the last assessment value before IMP.', 'unitOfMeasure': 'Micromoles per Liter (μmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants exposed to the IMP (regardless of the amount of treatment administered). Only those participants with data collected at each specified timepoint are reported.'}, {'type': 'SECONDARY', 'title': 'Part A: Maximum Observed Concentration (Cmax) Of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.64', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '7.41', 'spread': '6.29', 'groupId': 'OG001'}, {'value': '151', 'spread': '121', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. Cmax was defined as maximum concentration observed after the first infusion. The non-compartmental pharmacokinetic (PK) analysis was performed.', 'unitOfMeasure': 'Micrograms per milliliter (μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population included all participants exposed to the IMP (regardless of the amount of treatment administered), without any major or critical deviations related to IMP administration and for whom the PK data were considered sufficient and interpretable.'}, {'type': 'SECONDARY', 'title': 'Part A: Time to Reach Cmax (Tmax) of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.50', 'groupId': 'OG000', 'lowerLimit': '89.35', 'upperLimit': '96.33'}, {'value': '92.68', 'groupId': 'OG001', 'lowerLimit': '48.58', 'upperLimit': '119.17'}, {'value': '202.69', 'groupId': 'OG002', 'lowerLimit': '94.80', 'upperLimit': '310.58'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. Tmax was defined as time to reach Cmax. The non-compartmental PK analysis was performed.', 'unitOfMeasure': 'Hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants exposed to the IMP (regardless of the amount of treatment administered), without any major or critical deviations related to IMP administration and for whom the PK data were considered sufficient and interpretable.'}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time Zero to Time of the Last Concentration Observed Above the Lower Limit of Quantification (Clast) (AUClast) of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '540', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '879', 'spread': '99.0', 'groupId': 'OG001'}, {'value': '23900', 'spread': '41.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. AUClast was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to time of the Clast. The non-compartmental PK analysis was performed.', 'unitOfMeasure': 'Hours*micrograms per milliliter(h*μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants exposed to the IMP (regardless of the amount of treatment administered), without any major or critical deviations related to IMP administration and for whom the PK data were considered sufficient and interpretable.'}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '560', 'spread': '171', 'groupId': 'OG000'}, {'value': '1370', 'spread': '1350', 'groupId': 'OG001'}, {'value': '17800', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. AUCtau was defined as area under the plasma concentration versus time curve over the dosing interval. The non-compartmental PK analysis was performed.', 'unitOfMeasure': 'Hours*micrograms per milliliter(h*μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants exposed to the IMP (regardless of the amount of treatment administered), without any major or critical deviations related to IMP administration and for whom the PK data were considered sufficient and interpretable.'}, {'type': 'SECONDARY', 'title': 'Part A: Mean Plasma Trough Concentration Of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0114', 'spread': '0.0140', 'groupId': 'OG000'}, {'value': '0.678', 'spread': '0.994', 'groupId': 'OG001'}, {'value': '140', 'spread': '137', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.167', 'spread': '0.270', 'groupId': 'OG000'}, {'value': '7.30', 'spread': '7.13', 'groupId': 'OG001'}, {'value': '134', 'spread': '62.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.00111', 'spread': '0.00131', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '5.90', 'groupId': 'OG001'}, {'value': '62.0', 'spread': '87.7', 'groupId': 'OG002'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Mean and Standard deviation could not be determined as the values were below the lower limit of quantification (LLOQ). LLOQ was 0.0005 µg/mL', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '4.08', 'groupId': 'OG001'}, {'value': '146', 'spread': 'NA', 'comment': 'Standard deviation could not be determined when only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Days 15, 29, 43 and 57', 'description': 'Blood samples were collected at the specified timepoints. The non-compartmental Pharmacokinetic (PK) analysis was performed', 'unitOfMeasure': 'Micrograms per milliliter (μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants exposed to the IMP (regardless of the amount of treatment administered), without any major or critical deviations related to IMP administration and for whom the PK data were considered sufficient and interpretable.'}, {'type': 'SECONDARY', 'title': 'Part A: Number Of Participants With Anti-Isatuximab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'OG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Days 169', 'description': 'Plasma samples were collected to evaluate antibodies to Isatuximab. Plasma samples were screened for antibodies binding to Isatuximab. Post-baseline positive, defined as Anti-drug antibody (ADA) that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Number of participants with positive ADA have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA population included all participants exposed to the IMP (regardless of the amount of treatment administered) with at least one evaluable ADA sample (positive, negative or inconclusive) during the treatment emergent (TE) period.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With TEAEs And TESAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred from the time of the first IMP administration up to 30 days (included) after the last IMP administration. A SAE is defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With PCSA: Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were planned to be collected to determine the hematology laboratory significant abnormalities. PCSA values: abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Hb: ≤ 115 g/L (M); ≤ 95 g/L (F), ≥ 185 g/L (M); ≥ 165 g/L (F), Decrease from baseline ≥ 20 g/L; Hematocrit: ≤ 0.37 v/v (M); ≤ 0.32 v/v (F), ≥ 0.55 v/v (M); ≥ 0.5 v/v (F); Erythrocyte Count: ≥ 6 x 10\\^12/L); Platelet count: \\< 100 x 10\\^9/L, ≥ 700 x 10\\^9/L; Leukocytes: \\< 3 x 10\\^9/L (NB); \\< 2 x 10\\^9/L (B), ≥ 16 x 10\\^9/L; Neutrophils: \\< 1.5 x 10\\^9/L (B); \\< 1 x 10\\^9/L (B); Lymphocytes: \\> 4 x 10\\^9/L; Monocytes: \\> 0.7 x 10\\^9/L; Basophils: \\> 0.1 x 10\\^9/L; Eosinophils: \\> 0.5 x 10\\^9/L or \\> ULN (if ULN ≥ 0.5 x 10\\^9/L).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With PCSA: Clinical Chemistry And Electrolyte Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were planned to be collected to determine the clinical chemistry laboratory and electrolyte parameters significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Glucose: ≤ 3.9 mmol/L and \\< LLN, ≥ 11.1 mmol/L (unfasted); ≥ 7 mmol/L (fasted); Creatinine: ≥ 150 µmol/L, ≥ 30% change from baseline, ≥ 100% change from baseline, ALT: \\> 3 ULN, \\> 5 ULN, \\> 10 ULN; AST: \\> 3 ULN; ALP: \\> 1.5 ULN; Total Bilirubin: \\> 1.5 ULN, \\> 2 ULN; Sodium: ≤ 129 mmol/L; ≥ 160 mmol/L; Potassium: \\< 3 mmol/L, ≥ 5.5 mmol/L and Calcium', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Potentially Clinically Significant Abnormality: Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Urine samples were planned to be collected to determine the urinalysis parameter significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: pH ≤ 4.6 or ≥ 8.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Potentially Clinically Significant Abnormality: Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Vital signs were planned to be examined to determine the abnormalities. Vital signs included SSBP, SDBP, SHR and weight. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: SSBP: ≤ 95 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 160 mmHg and increase from baseline ≥20 mmHg; SDBP: ≤ 45 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; SHR: ≤ 50 bpm and decrease from baseline ≥ 20 bpm, ≥ 120 bpm and increase from baseline ≥ 20 bpm; Weight: ≥ 5% decrease from baseline, ≥5% increase from baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage Of Participants With Durable Hemoglobin Response By Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'From first dose of study drug (Day 1) up to end of study (Day 169)', 'description': 'Durable response was defined as Hb level ≥10 g/dL with an increase from baseline of ≥2 g/dL on three consecutive evaluable visits during the study period; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Overall Response Rate (Response [R] Or Complete Response [CR]) At Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Day 169', 'description': 'Overall response rate was defined as the percentage of participants with a R or CR over the evaluable participants. R was defined as an increase in Hb by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis might still be present. CR was defined as Hb ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, LDH, haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Absolute Change From Baseline In FACIT-Fatigue Scale Score At Day 85 And Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Baseline (Day 1) and Day 85 and Day 169', 'description': 'The FACIT-Fatigue scale is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0 to 4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52, where higher score (and positive change scores) indicated better functioning. Baseline was defined as the Day 1 pre-dose value.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Absolute Change From Baseline In LDH at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: LDH. Baseline was defined as the last assessment value before IMP', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Absolute Change From Baseline In Haptoglobin at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: Haptoglobin. Baseline was defined as the last assessment value before IMP', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Absolute Change From Baseline In Reticulocytes at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: Reticulocytes. Baseline was defined as the last assessment value before IMP', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Absolute Change From Baseline In Total Bilirubin at 1, 2, 4, 8, 12, and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: Total Bilirubin. Baseline was defined as the last assessment value before IMP', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Cmax Of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were planned to be collected at the specified timepoints. Cmax was defined as maximum concentration observed after the first infusion.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: AUCtau of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were planned to be collected at the specified timepoints. AUCtau was defined as area under the plasma concentration versus time curve over the dosing interval.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Mean Plasma Trough Concentration Of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'timeFrame': 'Post-dose on Days 15, 29, 43 and 57', 'description': 'Blood samples were planned to be collected at the specified timepoints.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Part B: Number Of Participants With Anti-Isatuximab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SCinjection Q2W through Day 71.'}], 'timeFrame': 'Up to Days 169', 'description': 'Plasma samples were planned to be collected to evaluate antibodies to Isatuximab. Plasma samples were planned to be screened for antibodies binding to Isatuximab. Post-baseline positive, defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'FG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'FG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}, {'id': 'FG003', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participants Who Completed the Study Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Switch of cohort due to retreatment criteria met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'As per Principal Investigator (PI) decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Early discontinuation as per PI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 6 centers in 6 countries. A total of 10 participants were screened from 09 September 2021 to 19 December 2022, of which 2 participants were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.', 'preAssignmentDetails': 'A total of 8 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study and included in 3 Cohorts in Part A. The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns. Hence Part B was not conducted, and no analysis was performed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.'}, {'id': 'BG001', 'title': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.'}, {'id': 'BG002', 'title': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.'}, {'id': 'BG003', 'title': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '24.7', 'groupId': 'BG000'}, {'value': '44.7', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '30.4', 'groupId': 'BG002'}, {'value': '50.9', 'spread': '19.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 to 64 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': '65 to 84 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants exposed to the investigational medicinal product (IMP) (regardless of the amount of treatment administered). The study was prematurely terminated based on strategic sponsor decision during Part A; not driven by any safety concerns, hence Part B was not conducted, and no analysis was performed.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-28', 'size': 4742960, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-06T12:52', 'hasProtocol': True}, {'date': '2023-07-19', 'size': 687003, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-06T12:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Study discontinuation based on strategic sponsor decision; not driven by any safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2020-12-01', 'resultsFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-23', 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) And Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of study drug (Day 1) up to 30 days after last study intervention administration, approximately 101 days', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred from the time of the first IMP administration up to 30 days (included) after the last IMP administration. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.'}, {'measure': 'Part A: Number of Participants With Potentially Clinically Significant Abnormality (PCSA): Hematology', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were collected to determine the hematology laboratory significant abnormalities. PCSA values: abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Hemoglobin (Hb): ≤ 115 grams per Liter (g/L) (Male\\[M\\]); ≤ 95 g/L (Female\\[F\\]), ≥ 185 g/L (M); ≥ 165 g/L (F), Decrease from baseline ≥ 20 g/L; Hematocrit: ≤ 0.37 volume per volume (v/v) (M); ≤ 0.32 v/v (F), ≥ 0.55 v/v (M); ≥ 0.5 v/v (F); Erythrocyte Count: ≥ 6 x 10\\^12 per Liter (/L); Platelet count: \\< 100 x 10\\^9/L, ≥ 700 x 10\\^9/L; Leukocytes: \\< 3 x 10\\^9/L (Non-Black \\[NB\\]); \\< 2 x 10\\^9/L (Black \\[B\\]), ≥ 16 x 10\\^9/L; Neutrophils: \\< 1.5 x 10\\^9/L (B); \\< 1 x 10\\^9/L (B); Lymphocytes: \\> 4 x 10\\^9/L; Monocytes: \\> 0.7 x 10\\^9/L; Basophils: \\> 0.1 x 10\\^9/L; Eosinophils: \\> 0.5 x 10\\^9/L or \\> Upper limit of Normal (ULN) (if ULN ≥ 0.5 x 10\\^9/L).'}, {'measure': 'Part A: Number of Participants With PCSA: Clinical Chemistry And Electrolyte Parameters', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were collected to determine the clinical chemistry laboratory and electrolyte parameters significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Glucose: ≤ 3.9 millimoles per Liter (mmol/L) and \\< Lower limit of normal (LLN), ≥ 11.1 mmol/L (unfasted); ≥ 7 mmol/L (fasted); Creatinine: ≥ 150 micromoles (µmol)/L, ≥ 30% change from baseline, ≥ 100% change from baseline, Alanine Aminotransferase (ALT): \\> 3 ULN, \\> 5 ULN, \\> 10 ULN; Aspartate Aminotransferase (AST): \\> 3 ULN; Alkaline Phosphatase (ALP): \\> 1.5 ULN; Total Bilirubin: \\> 1.5 ULN, \\> 2 ULN; Sodium: ≤ 129 mmol/L, ≥ 160 mmol/L and Potassium: \\< 3 mmol/L, ≥ 5.5 mmol/L.'}, {'measure': 'Part A: Number of Participants With Potentially Clinically Significant Abnormality: Urinalysis', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Urine samples were collected to determine the urinalysis parameter significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: pH: ≤ 4.6 or ≥ 8.'}, {'measure': 'Part A: Number of Participants With Potentially Clinically Significant Abnormality: Vital Signs', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Vital signs were examined to determine the abnormalities. Vital signs included Sitting systolic blood pressure (SSBP), Sitting diastolic blood pressure (SDBP), Sitting heart rate (SHR) and weight. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: SSBP: ≤95 millimeters of mercury (mmHg) and decrease from baseline ≥20 mmHg; ≥160 mmHg and increase from baseline ≥20 mmHg; SDBP: ≤45 mmHg and decrease from baseline ≥10 mmHg, ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; SHR: ≤ 50 beats per minute (bpm) and decrease from baseline ≥ 20 bpm, ≥120 bpm and increase from baseline ≥ 20 bpm; Weight: ≥ 5% decrease from baseline, ≥5% increase from baseline.'}, {'measure': 'Part B: Overall Response Rate (Response [R] Or Complete Response [CR]) At Day 85', 'timeFrame': 'Day 85', 'description': 'Overall response rate was defined as the percentage of participants with a response (R) or complete response (CR) over the evaluable participants. R was defined as an increase in Hb by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis might still be present. CR was defined as Hb ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, Lactate dehydrogenase \\[LDH\\], haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks.'}], 'secondaryOutcomes': [{'measure': 'Part A: Cohorts 2 and 3: Overall Response Rate (Response [R] Or Complete Response [CR]) At Day 85 And Day 169', 'timeFrame': 'Day 85 and Day 169', 'description': 'Overall response rate was defined as the percentage of participants with a R or CR over the evaluable participants. R was defined as an increase in Hb by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis might still be present. CR was defined as Hb ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, LDH, haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks'}, {'measure': 'Part A: Cohorts 2 and 3: Percentage Of Participants With Durable Hemoglobin (Hb) Response By Day 169', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study (Day 169)', 'description': 'Durable response was defined as Hb level ≥10 g/dL with an increase from baseline of ≥2 g/dL on three consecutive evaluable visits during the study period; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.'}, {'measure': 'Part A: Cohorts 2 and 3: Absolute Change From Baseline in Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Scale Score At Day 85 and Day 169', 'timeFrame': 'Baseline (Day 1), Day 85 and Day 169', 'description': 'The FACIT-Fatigue scale is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0 to 4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52, where higher score (and positive change scores) indicated better functioning. Baseline was defined as the Day 1 pre-dose value.'}, {'measure': 'Part A: Absolute Change From Baseline In Lactate Dehydrogenase (LDH) at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: LDH. Baseline is defined as the last assessment value before IMP.'}, {'measure': 'Part A: Absolute Change From Baseline In Haptoglobin at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: Haptoglobin. Baseline was defined as the last assessment value before IMP.'}, {'measure': 'Part A: Absolute Change From Baseline In Reticulocytes at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: Reticulocytes. Baseline was defined as the last assessment value before IMP.'}, {'measure': 'Part A: Absolute Change From Baseline In Total Bilirubin at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Cohort 1 : Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, and 12; Cohorts 2 and 3: Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were collected to evaluate the effect of Isatuximab on marker of hemolysis: Total Bilirubin. Baseline was defined as the last assessment value before IMP.'}, {'measure': 'Part A: Maximum Observed Concentration (Cmax) Of Isatuximab', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. Cmax was defined as maximum concentration observed after the first infusion. The non-compartmental pharmacokinetic (PK) analysis was performed.'}, {'measure': 'Part A: Time to Reach Cmax (Tmax) of Isatuximab', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. Tmax was defined as time to reach Cmax. The non-compartmental PK analysis was performed.'}, {'measure': 'Part A: Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time Zero to Time of the Last Concentration Observed Above the Lower Limit of Quantification (Clast) (AUClast) of Isatuximab', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. AUClast was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to time of the Clast. The non-compartmental PK analysis was performed.'}, {'measure': 'Part A: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Isatuximab', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were collected at the specified timepoints. AUCtau was defined as area under the plasma concentration versus time curve over the dosing interval. The non-compartmental PK analysis was performed.'}, {'measure': 'Part A: Mean Plasma Trough Concentration Of Isatuximab', 'timeFrame': 'Post-dose on Days 15, 29, 43 and 57', 'description': 'Blood samples were collected at the specified timepoints. The non-compartmental Pharmacokinetic (PK) analysis was performed'}, {'measure': 'Part A: Number Of Participants With Anti-Isatuximab Antibodies', 'timeFrame': 'Up to Days 169', 'description': 'Plasma samples were collected to evaluate antibodies to Isatuximab. Plasma samples were screened for antibodies binding to Isatuximab. Post-baseline positive, defined as Anti-drug antibody (ADA) that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Number of participants with positive ADA have been reported.'}, {'measure': 'Part B: Number of Participants With TEAEs And TESAEs', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred from the time of the first IMP administration up to 30 days (included) after the last IMP administration. A SAE is defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.'}, {'measure': 'Part B: Number of Participants With PCSA: Hematology', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were planned to be collected to determine the hematology laboratory significant abnormalities. PCSA values: abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Hb: ≤ 115 g/L (M); ≤ 95 g/L (F), ≥ 185 g/L (M); ≥ 165 g/L (F), Decrease from baseline ≥ 20 g/L; Hematocrit: ≤ 0.37 v/v (M); ≤ 0.32 v/v (F), ≥ 0.55 v/v (M); ≥ 0.5 v/v (F); Erythrocyte Count: ≥ 6 x 10\\^12/L); Platelet count: \\< 100 x 10\\^9/L, ≥ 700 x 10\\^9/L; Leukocytes: \\< 3 x 10\\^9/L (NB); \\< 2 x 10\\^9/L (B), ≥ 16 x 10\\^9/L; Neutrophils: \\< 1.5 x 10\\^9/L (B); \\< 1 x 10\\^9/L (B); Lymphocytes: \\> 4 x 10\\^9/L; Monocytes: \\> 0.7 x 10\\^9/L; Basophils: \\> 0.1 x 10\\^9/L; Eosinophils: \\> 0.5 x 10\\^9/L or \\> ULN (if ULN ≥ 0.5 x 10\\^9/L).'}, {'measure': 'Part B: Number of Participants With PCSA: Clinical Chemistry And Electrolyte Parameters', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Blood samples were planned to be collected to determine the clinical chemistry laboratory and electrolyte parameters significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Glucose: ≤ 3.9 mmol/L and \\< LLN, ≥ 11.1 mmol/L (unfasted); ≥ 7 mmol/L (fasted); Creatinine: ≥ 150 µmol/L, ≥ 30% change from baseline, ≥ 100% change from baseline, ALT: \\> 3 ULN, \\> 5 ULN, \\> 10 ULN; AST: \\> 3 ULN; ALP: \\> 1.5 ULN; Total Bilirubin: \\> 1.5 ULN, \\> 2 ULN; Sodium: ≤ 129 mmol/L; ≥ 160 mmol/L; Potassium: \\< 3 mmol/L, ≥ 5.5 mmol/L and Calcium'}, {'measure': 'Part B: Number of Participants With Potentially Clinically Significant Abnormality: Urinalysis', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Urine samples were planned to be collected to determine the urinalysis parameter significant abnormalities. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: pH ≤ 4.6 or ≥ 8.'}, {'measure': 'Part B: Number of Participants With Potentially Clinically Significant Abnormality: Vital Signs', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study, approximately 169 days', 'description': 'Vital signs were planned to be examined to determine the abnormalities. Vital signs included SSBP, SDBP, SHR and weight. PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: SSBP: ≤ 95 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 160 mmHg and increase from baseline ≥20 mmHg; SDBP: ≤ 45 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; SHR: ≤ 50 bpm and decrease from baseline ≥ 20 bpm, ≥ 120 bpm and increase from baseline ≥ 20 bpm; Weight: ≥ 5% decrease from baseline, ≥5% increase from baseline.'}, {'measure': 'Part B: Percentage Of Participants With Durable Hemoglobin Response By Day 169', 'timeFrame': 'From first dose of study drug (Day 1) up to end of study (Day 169)', 'description': 'Durable response was defined as Hb level ≥10 g/dL with an increase from baseline of ≥2 g/dL on three consecutive evaluable visits during the study period; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.'}, {'measure': 'Part B: Overall Response Rate (Response [R] Or Complete Response [CR]) At Day 169', 'timeFrame': 'Day 169', 'description': 'Overall response rate was defined as the percentage of participants with a R or CR over the evaluable participants. R was defined as an increase in Hb by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis might still be present. CR was defined as Hb ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, LDH, haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks'}, {'measure': 'Part B: Absolute Change From Baseline In FACIT-Fatigue Scale Score At Day 85 And Day 169', 'timeFrame': 'Baseline (Day 1) and Day 85 and Day 169', 'description': 'The FACIT-Fatigue scale is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0 to 4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52, where higher score (and positive change scores) indicated better functioning. Baseline was defined as the Day 1 pre-dose value.'}, {'measure': 'Part B: Absolute Change From Baseline In LDH at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: LDH. Baseline was defined as the last assessment value before IMP'}, {'measure': 'Part B: Absolute Change From Baseline In Haptoglobin at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: Haptoglobin. Baseline was defined as the last assessment value before IMP'}, {'measure': 'Part B: Absolute Change From Baseline In Reticulocytes at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: Reticulocytes. Baseline was defined as the last assessment value before IMP'}, {'measure': 'Part B: Absolute Change From Baseline In Total Bilirubin at 1, 2, 4, 8, 12, and 24 Weeks', 'timeFrame': 'Baseline (Day 1) and pre-dose at Weeks 1, 2, 4, 8, 12, and 24', 'description': 'Blood samples were planned to be collected to evaluate the effect of Isatuximab on marker of hemolysis: Total Bilirubin. Baseline was defined as the last assessment value before IMP'}, {'measure': 'Part B: Cmax Of Isatuximab', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were planned to be collected at the specified timepoints. Cmax was defined as maximum concentration observed after the first infusion.'}, {'measure': 'Part B: AUCtau of Isatuximab', 'timeFrame': 'Post-dose on Day 1', 'description': 'Blood samples were planned to be collected at the specified timepoints. AUCtau was defined as area under the plasma concentration versus time curve over the dosing interval.'}, {'measure': 'Part B: Mean Plasma Trough Concentration Of Isatuximab', 'timeFrame': 'Post-dose on Days 15, 29, 43 and 57', 'description': 'Blood samples were planned to be collected at the specified timepoints.'}, {'measure': 'Part B: Number Of Participants With Anti-Isatuximab Antibodies', 'timeFrame': 'Up to Days 169', 'description': 'Plasma samples were planned to be collected to evaluate antibodies to Isatuximab. Plasma samples were planned to be screened for antibodies binding to Isatuximab. Post-baseline positive, defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['(wAIHA)'], 'conditions': ['Warm Autoimmune Hemolytic Anemia (wAIHA)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=25198&tenant=MT_SNY_9011', 'label': 'ACT16832 Plain language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA\n* Part B: To evaluate the efficacy of the selected dose in adults with wAIHA\n\nSecondary Objectives:\n\n* Part A (Cohorts 2 and 3 only)\n* To evaluate the efficacy of isatuximab in adults with wAIHA\n* To evaluate the durability of response to isatuximab and time to response\n* To evaluate the impact of isatuximab treatment on fatigue\n\nPart B\n\n* To evaluate the safety and tolerability of isatuximab in adults with wAIHA\n* To evaluate the durability of response to isatuximab and time to response\n* To evaluate the impact of isatuximab treatment on fatigue\n\nParts A (all Cohorts) and B\n\n* To evaluate the effect of isatuximab on markers of hemolysis\n* To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA\n* To evaluate the immunogenicity of isatuximab', 'detailedDescription': '28 weeks (including screening)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Participant must be ≥18 to years of age, inclusive, at the time of signing the informed consent.\n\n \\- Males and females with a confirmed diagnosis of primary w AIHA or systemic lupus erythematosus (SLE)-associated w AIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations) who meet the following criteria:\n 1. Hemoglobin level \\<10 g/dL at screening.\n 2. Hemolysis (haptoglobin ≤40 mg/dL and total or indirect/unconjugated bilirubin above the upper limit of normal).\n 3. Positive direct antiglobulin test (DAT) (IgG or IgG + complement C3d pattern or IgM warm autoantibodies (positive dual DAT)).\n\n * Participants who have previously failed to maintain a sustained response after treatment with corticosteroids (corticosteroid-refractory or corticosteroid-dependent primary wAIHA).\n * Part A only: Participants who have previously failed to maintain a sustained response after treatment with rituximab (or other anti-CD20 monoclonal antibodies). The last dose of the anti-CD20 antibody must have been administered at least 12 weeks before enrollment.\n * Part B: Participants who have had an insufficient response to at least 1 prior therapy in addition to corticosteroids (splenectomy is regarded as a prior therapy).\n * Contraceptive use by men and women\n\n Exclusion criteria:\n* Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator.\n\n * Serious infection that required hospitalization within 3 months prior to enrollment.\n * Secondary wAIHA from any cause including drugs, lymphoproliferative disorders, infectious or autoimmune disease (SLE without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations is allowed), or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed.\n * History of coagulation or bleeding disorders (Evans Syndrome is allowed).\n * Uncontrolled or active HBV or HCV infection\n * HIV infection.\n * Serum gammaglobulin levels \\<3 g/L.\n * Females who are pregnant, lactating, or considered unreliable with respect to contraceptive practice.\n * Concurrent treatment with corticosteroids, unless the participant has been on a stable daily dose for ≥ 15 days prior to enrollment.\n * Treatment with cyclophosphamide within 4 weeks prior to enrollment.\n * Treatment with cytotoxic drugs (other than cyclophosphamide) within 12 weeks prior to enrollment.\n * Treatment with non-cytotoxic, immunomodulatory drugs (including but not limited to Cyclosporine, Sirolimus, Tacrolimus, Idelalisib, Ibrutinib), excluding biologic agents, within 4 weeks prior to enrollment.\n * Treatment with any biologic agent within 12 weeks prior to enrollment.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04661033', 'briefTitle': 'Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia', 'orgStudyIdInfo': {'id': 'ACT16832'}, 'secondaryIdInfos': [{'id': 'U1111-1255-5350', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2020-003880-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'description': 'Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \\[mL\\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.', 'interventionNames': ['Drug: Isatuximab SAR650984']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.', 'interventionNames': ['Drug: Isatuximab SAR650984']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'description': 'Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.', 'interventionNames': ['Drug: Isatuximab SAR650984']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Isatuximab up to 560 mg SC Q2W x6', 'description': 'Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71', 'interventionNames': ['Drug: Isatuximab SAR650984']}], 'interventions': [{'name': 'Isatuximab SAR650984', 'type': 'DRUG', 'description': 'Pharmaceutical form:Solution for injection Route of administration: Subcutaneous', 'armGroupLabels': ['Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2', 'Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6', 'Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6', 'Part B: Isatuximab up to 560 mg SC Q2W x6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center Site Number : 8400004', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Investigational Site Number : 2500001', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760001', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Investigational Site Number : 3800001', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Investigational Site Number : 5280001', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': 'NW1 2PG', 'city': 'London', 'state': 'London, City of', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260001', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}