Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT04697056
Status:
TERMINATED
Last Update Posted:
2025-09-16
First Post:
2020-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007057', 'term': 'Ichthyosis'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400', 'title': 'Vanda Pharmaceuticals', 'organization': 'Vanda Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As a result of insufficient recruitment of participants, this study was terminated.'}}, 'adverseEventsModule': {'timeFrame': 'From first dose up to study termination (maximum up to 9.4 weeks)', 'description': 'Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every four 4 (Days 29, 57 and 85) by subcutaneous injection.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every four 4 (Days 29, 57 and 85) by subcutaneous injection.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Herpes simplex reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Inguinal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling \\& percentage of body surface area (BSA) affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 body regions (BR) \\[A1: head \\& neck (H\\&N), A2: upper limbs (UL), A3: trunk (T), A4: lower limbs (LL)\\]. Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value(0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6).Total extent was determined using multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-Erythema (E)= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-Scaling (S)= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in IASI Total Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24)\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24)\n\nIASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}], 'timeFrame': 'Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24)\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24)\n\nIASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IASI-E Scores at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4\n\nIASI-E score ranged from 0 - 24, higher score indicated worse disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IASI-S Scores at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on day 1 and thereafter every 4 weeks (days 29, 57 and 85) by subcutaneous injection.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4\n\nIASI-S score ranged from 0 - 24, higher score indicated worse disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in IASI-E Scores at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on day 1 and thereafter every four weeks (days 29, 57 and 85) by subcutaneous injection.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4\n\nIASI-E score ranged from 0 - 24, higher score indicated worse disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in IASI-S Scores at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}], 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4\n\nIASI-S score ranged from 0 - 24, higher score indicated worse disease state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to study termination (maximum up to 9.4 weeks)', 'description': 'An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study treatment that did not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening adverse event, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. An adverse event was considered TE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Termination of the participant participation by the Investigator or Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants with confirmed diagnosis of ichthyosis by genetic testing of ichthyosis were enrolled into the study.', 'preAssignmentDetails': '7 participants were screened for eligibility and 5 participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '20.15', 'groupId': 'BG000'}, {'value': '66.0', 'groupId': 'BG001'}, {'value': '44.4', 'spread': '21.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) analysis set included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-30', 'size': 7708805, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-17T02:59', 'hasProtocol': True}, {'date': '2022-01-12', 'size': 2186939, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-17T03:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Administrative Reason', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2020-12-23', 'resultsFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-02-06', 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling \\& percentage of body surface area (BSA) affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 body regions (BR) \\[A1: head \\& neck (H\\&N), A2: upper limbs (UL), A3: trunk (T), A4: lower limbs (LL)\\]. Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value(0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6).Total extent was determined using multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-Erythema (E)= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-Scaling (S)= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in IASI Total Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24)\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24)\n\nIASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.'}, {'measure': 'Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16', 'timeFrame': 'Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24)\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24)\n\nIASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.'}, {'measure': 'Change From Baseline in IASI-E Scores at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4\n\nIASI-E score ranged from 0 - 24, higher score indicated worse disease state.'}, {'measure': 'Change From Baseline in IASI-S Scores at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4\n\nIASI-S score ranged from 0 - 24, higher score indicated worse disease state.'}, {'measure': 'Percent Change From Baseline in IASI-E Scores at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4\n\nIASI-E score ranged from 0 - 24, higher score indicated worse disease state.'}, {'measure': 'Percent Change From Baseline in IASI-S Scores at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \\& percentage of BSA affected. Degree of erythema \\& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL).\n\nIASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4\n\nIASI-S score ranged from 0 - 24, higher score indicated worse disease state.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose up to study termination (maximum up to 9.4 weeks)', 'description': 'An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study treatment that did not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening adverse event, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. An adverse event was considered TE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IL-36 Receptor', 'Interleukin 36', 'Imsidolimab'], 'conditions': ['Ichthyosis']}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of imsidolimab in Participants with Ichthyosis', 'detailedDescription': 'This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in adolescent and adult participants with ichthyosis. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with ichthyosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Ichthyosis\n* IASI total score ≥ 18, erythema score ≥ 2\n* Participant has been using emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily at the same frequency throughout the study\n\nExclusion Criteria:\n\n* A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.'}, 'identificationModule': {'nctId': 'NCT04697056', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis', 'orgStudyIdInfo': {'id': 'ANB019-206'}, 'secondaryIdInfos': [{'id': '2020-003476-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imsidolimab', 'description': 'Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.', 'interventionNames': ['Drug: Imsidolimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'Imsidolimab', 'type': 'DRUG', 'otherNames': ['ANB019'], 'description': 'Humanized Monoclonal Antibody', 'armGroupLabels': ['Imsidolimab']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Site 106', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Site 104', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 112', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site 101', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site 102', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 107', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Site 105', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}