Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-01 @ 11:16 AM
Study NCT ID:
NCT04654468
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006457', 'term': 'Hemoglobinuria, Paroxysmal'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From enrollment until primary completion date cutoff (up to approximately 25 weeks)', 'description': 'Safety population included all enrolled participants who received at least one dose of crovalimab.', 'eventGroups': [{'id': 'EG000', 'title': 'CROVALIMAB', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 46, 'seriousNumAtRisk': 51, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Alpha hydroxybutyrate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 27, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Blood bilirubin unconjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 25, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 29, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Abdominal wall mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percentage of Participants With Hemolysis Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.66', 'groupId': 'OG000', 'lowerLimit': '67.78', 'upperLimit': '86.59'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 5 up to Week 25', 'description': 'A Generalized Estimating Equation (GEE) was used to estimate the population-average percentage of the participants with hemolysis control (measured by lactate dehydrogenase (LDH) ≤1.5 x upper limit of normal (ULN)) from Week 5 to Week 25 taking account of the intra-patient and inter-patient correlation between LDH control statuses across visits. The dependent variable was the binary indicator for hemolysis control. Independent variables are categorical effects of visits, continuous baseline LDH.', 'unitOfMeasure': 'mean percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Population (PAP) included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.'}, {'type': 'PRIMARY', 'title': 'Difference in Percentage of Participants With Transfusion Avoidance (TA) From Baseline Through Week 25 and Within 24 Weeks Prior to Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.98', 'groupId': 'OG000', 'lowerLimit': '34.30', 'upperLimit': '65.05'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Percentage of participants who achieved TA from baseline through Week 25 were compared with the percentage of participants who reported TA within 24 weeks prior to screening.', 'statisticalMethod': 'Paired McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks Prior to Screening, Baseline to Week 25', 'description': 'TA was defined as participants who were packed red blood cell (pRBC) transfusion-free and did not require transfusion per protocol-specified guidelines. TA within 24 weeks prior to screening was based on the pRBC transfusion history in the medical records. Reported in this outcome measure is the difference in the percentage of participants between "baseline through Week 25" and "within 24 weeks prior to screening". 95% Confidence Interval (CI) for the difference between the percentage of participants with transfusion avoidance between Pre-screening and Post-baseline is calculated using the Newcombe method.\n\nScreening= Day -28 to Day -1 and Baseline= Day 1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Breakthrough Hemolysis (BTH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '14.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 25', 'description': 'BTH was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath \\[dyspnea\\], anemia \\[hemoglobin \\< 10 grams per deciliter (g/dL)\\], major adverse vascular event \\[MAVE, including thrombosis\\], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2xULN after a prior LDH reduction to ≤1.5xULN from the start of study treatment. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to have experienced a BTH event. Percentages have been rounded off to the first decimal point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Stabilized Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '36.77', 'upperLimit': '65.05'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 25', 'description': 'Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to not have hemoglobin stabilization.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fatigue in Adults Aged >=18 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.77', 'spread': '8.53', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.67', 'spread': '8.02', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.08', 'spread': '9.28', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.15', 'spread': '10.61', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.77', 'spread': '9.63', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 5, Week 9, Week 17, Week 25', 'description': 'Fatigue was assessed using functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. FACIT-F is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Items are scored on a response scale that ranges from 0 ("not at all") to 4 ("very much so"). Relevant items are reverse scored, and all the items are summed to create a total score range from 0 to 52, with 0 being the worst possible score and 52 being the best possible score. A higher score indicates low fatigue severity. A positive mean change indicates improvement. FACIT-F was assessed in adult participants only. FACIT-F assessment was unintentionally missed in the Schedule of Activities (SoA) table, which site used to guide the assessments at each timepoint. Therefore, data were not collected at Week 25.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion. Overall number analyzed is the number of participants ≥18 years with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity, and Infections (Including Meningococcal Meningitis)', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Trough Serum Concentration of Crovalimab Over Time', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Crovalimab', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Crovalimab', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Terminal Complement Activity as Measured by Liposome Immunoassay (LIA)', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Change Over Time in Total and Free C5 Concentration', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Observed Value in Absolute Reticulocyte Count', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Observed Value in Free Hemoglobin', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Observed Value in Haptoglobin', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Absolute Reticulocyte Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9411', 'spread': '66.0292', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of crovalimab. Number of participants analyzed is the number of participants with data available for analysis at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Free Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.6180', 'spread': '51.8421', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of crovalimab. Number of participants analyzed is the number of participants with data available for analysis at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Haptoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '295.1351', 'spread': '1735.4180', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of crovalimab. Number of participants analyzed is the number of participants with data available for analysis at the specified timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 milligrams (mg) (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight \\>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) once every 4 weeks (Q4W) from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab Q4W.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ongoing in the Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 5 investigative sites in China.', 'preAssignmentDetails': 'A total of 51 participants with a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) were enrolled in the study and received at least 1 dose of crovalimab.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Crovalimab', 'description': 'Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight \\>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \\>=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of crovalimab.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-23', 'size': 3760509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-29T02:09', 'hasProtocol': True}, {'date': '2021-02-08', 'size': 1046124, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-06T01:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2020-11-30', 'resultsFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-05-09', 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percentage of Participants With Hemolysis Control', 'timeFrame': 'From Week 5 up to Week 25', 'description': 'A Generalized Estimating Equation (GEE) was used to estimate the population-average percentage of the participants with hemolysis control (measured by lactate dehydrogenase (LDH) ≤1.5 x upper limit of normal (ULN)) from Week 5 to Week 25 taking account of the intra-patient and inter-patient correlation between LDH control statuses across visits. The dependent variable was the binary indicator for hemolysis control. Independent variables are categorical effects of visits, continuous baseline LDH.'}, {'measure': 'Difference in Percentage of Participants With Transfusion Avoidance (TA) From Baseline Through Week 25 and Within 24 Weeks Prior to Screening', 'timeFrame': '24 Weeks Prior to Screening, Baseline to Week 25', 'description': 'TA was defined as participants who were packed red blood cell (pRBC) transfusion-free and did not require transfusion per protocol-specified guidelines. TA within 24 weeks prior to screening was based on the pRBC transfusion history in the medical records. Reported in this outcome measure is the difference in the percentage of participants between "baseline through Week 25" and "within 24 weeks prior to screening". 95% Confidence Interval (CI) for the difference between the percentage of participants with transfusion avoidance between Pre-screening and Post-baseline is calculated using the Newcombe method.\n\nScreening= Day -28 to Day -1 and Baseline= Day 1.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Breakthrough Hemolysis (BTH)', 'timeFrame': 'Baseline, Week 25', 'description': 'BTH was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath \\[dyspnea\\], anemia \\[hemoglobin \\< 10 grams per deciliter (g/dL)\\], major adverse vascular event \\[MAVE, including thrombosis\\], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2xULN after a prior LDH reduction to ≤1.5xULN from the start of study treatment. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to have experienced a BTH event. Percentages have been rounded off to the first decimal point.'}, {'measure': 'Percentage of Participants With Stabilized Hemoglobin', 'timeFrame': 'Baseline, Week 25', 'description': 'Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to not have hemoglobin stabilization.'}, {'measure': 'Change From Baseline in Fatigue in Adults Aged >=18 Years', 'timeFrame': 'Baseline, Week 2, Week 5, Week 9, Week 17, Week 25', 'description': 'Fatigue was assessed using functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. FACIT-F is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Items are scored on a response scale that ranges from 0 ("not at all") to 4 ("very much so"). Relevant items are reverse scored, and all the items are summed to create a total score range from 0 to 52, with 0 being the worst possible score and 52 being the best possible score. A higher score indicates low fatigue severity. A positive mean change indicates improvement. FACIT-F was assessed in adult participants only. FACIT-F assessment was unintentionally missed in the Schedule of Activities (SoA) table, which site used to guide the assessments at each timepoint. Therefore, data were not collected at Week 25.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 7 years'}, {'measure': 'Percentage of Participants With Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity, and Infections (Including Meningococcal Meningitis)', 'timeFrame': 'Up to 7 years'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation', 'timeFrame': 'Up to 7 years'}, {'measure': 'Trough Serum Concentration of Crovalimab Over Time', 'timeFrame': 'Up to 7 years'}, {'measure': 'Serum Concentrations of Crovalimab', 'timeFrame': 'Up to 7 years'}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Crovalimab', 'timeFrame': 'Up to 7 years'}, {'measure': 'Terminal Complement Activity as Measured by Liposome Immunoassay (LIA)', 'timeFrame': 'Up to 7 years'}, {'measure': 'Change Over Time in Total and Free C5 Concentration', 'timeFrame': 'Up to 7 years'}, {'measure': 'Observed Value in Absolute Reticulocyte Count', 'timeFrame': 'Up to 7 years'}, {'measure': 'Observed Value in Free Hemoglobin', 'timeFrame': 'Up to 7 years'}, {'measure': 'Observed Value in Haptoglobin', 'timeFrame': 'Up to 7 years'}, {'measure': 'Percent Change From Baseline in Absolute Reticulocyte Count', 'timeFrame': 'Baseline, Week 25'}, {'measure': 'Percent Change From Baseline in Free Hemoglobin', 'timeFrame': 'Baseline, Week 25'}, {'measure': 'Percent Change From Baseline in Haptoglobin', 'timeFrame': 'Baseline, Week 25'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paroxysmal Nocturnal Hemoglobinuria']}, 'referencesModule': {'references': [{'pmid': '39535306', 'type': 'DERIVED', 'citation': 'Roth A, Fu R, He G, Alzahrani H, Chou SC, Hicheri Y, Kazmierczak M, Recova VL, Uchiyama M, Vladareanu AM, Beveridge L, Buatois S, Buri M, Compagno N, Shi D, Balachandran N, Sreckovic S, Scheinberg P. Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH): Pooled Results From the Phase 3 COMMODORE Studies. Eur J Haematol. 2025 Feb;114(2):373-382. doi: 10.1111/ejh.14339. Epub 2024 Nov 13.'}, {'pmid': '37421604', 'type': 'DERIVED', 'citation': 'Liu H, Xia L, Weng J, Zhang F, He C, Gao S, Jia J, Chang AC, Lundberg P, Shi J, Sima CS, Sostelly A, Sreckovic S, Xiao Z, Zhang Z, Fu R. Efficacy and safety of the C5 inhibitor crovalimab in complement inhibitor-naive patients with PNH (COMMODORE 3): A multicenter, Phase 3, single-arm study. Am J Hematol. 2023 Sep;98(9):1407-1414. doi: 10.1002/ajh.26998. Epub 2023 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'This study will enroll participants aged 12 years or older with a body weight ≥ 40 kilograms (kg) diagnosed with PNH who have not been previously treated with complement inhibitor therapy. Approximately 50 participants will be treated with Crovalimab for at least 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight ≥ 40 kg at screening\n* Willingness and ability to comply with all study visits and procedures\n* Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry\n* LDH Levels ≥ 2x the ULN at screening\n* Participants who have at least four transfusions during 12 months prior to screening (documented in the medical record)\n* Presence of one or more of the PNH-related signs or symptoms within 3 months of screening\n* Vaccination against Neisseria meningitidis serotypes A, C, W, and Y \\< 3 years prior to initiation of study treatment (Day 1)\n* Vaccination against Haemophilius influenzae type B and Streptococcus pneumonia according to national vaccination recommendations\n* For participants receiving other therapies (e.g., immunosuppressants, corticosteroids): stable dose for ≥ 28 days prior to screening and up to the first drug administration\n* Adequate hepatic and renal function\n* Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 46 weeks (approximately 10.5 months) after the final dose of crovalimab\n* Platelet count ≥30,000 per cubic millimeter (mm\\^3) at screening\n* ANC \\> 500/microlitres (μl) at screening\n\nExclusion Criteria:\n\n* Current or previous treatment with a complement inhibitor\n* History of allogeneic bone marrow transplantation\n* History of Neisseria meningitidis infection within 6 months prior to screening and up to first drug administration\n* Known or suspected immune or hereditary complement deficiency\n* Known HIV infection with cluster of differentiation 4 (CD4) count \\< 200 cells/µl within 24 weeks prior to screening\n* Infection requiring hospitalization or treatment with IV antibiotics within 28 days prior to screening and up to the first drug administration, or oral antibiotics within 14 days prior to screening and up to the first drug administration\n* Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration\n* Presence of fever (≥ 38˚C) within 7 days before the first drug administration\n* Splenectomy \\< 6 months before screening\n* History of malignancy within 5 years prior to screening and up to the first drug administration\n* Pregnant or intending to become pregnant during the study or within 46 weeks (10.5 months) after the final dose of study treatment\n* Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater'}, 'identificationModule': {'nctId': 'NCT04654468', 'acronym': 'COMMODORE 3', 'briefTitle': 'A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition', 'orgStudyIdInfo': {'id': 'YO42311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crovalimab', 'description': 'Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.', 'interventionNames': ['Drug: Crovalimab']}], 'interventions': [{'name': 'Crovalimab', 'type': 'DRUG', 'description': 'Crovalimab will be administered at a dose of 1000 milligrams (mg) IV (for participants with body weight between 40 and 100 kg) or 1500 mg IV (for participants with body weight ≥ 100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100 kg) or 1020 mg SC (for participants with body weight ≥ 100 kg). Dosing schedule will be as described above.', 'armGroupLabels': ['Crovalimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300020', 'city': 'Tianjin', 'country': 'China', 'facility': 'Institute of Hematology and Hospital of Blood Disease', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300052', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '430022', 'city': 'Wuhan', 'country': 'China', 'facility': 'Union Hospital Tongji Medical College Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}