Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-01-03 @ 6:35 PM
Study NCT ID:
NCT05041803
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2021-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trial@sunpharma.com', 'phone': '9122 66455645', 'title': 'Head, Regulatory Affairs', 'organization': 'Sun Pharmaceutical Industries Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '108 Weeks', 'description': 'Subjects could be counted in both CTP-543 dose groups due to dose changes.', 'eventGroups': [{'id': 'EG000', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, twice a day', 'otherNumAtRisk': 367, 'deathsNumAtRisk': 367, 'otherNumAffected': 176, 'seriousNumAtRisk': 367, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, twice a day', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 273, 'otherNumAffected': 127, 'seriousNumAtRisk': 273, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 46, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 30, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 118, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 71, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asymptomatic COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 92, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 65, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 81, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 46, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 50, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 53, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': "Bartholin's abscess", 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis E', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Bartholin's cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 367, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, twice a day'}, {'id': 'OG001', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '308', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '108 weeks', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of CTP-543 in this study. Subjects could be counted in both CTP-543 dose groups due to dose changes.'}, {'type': 'PRIMARY', 'title': 'Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, twice daily'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID to CTP-543 12 mg BID', 'description': 'Participants received CTP-543 8 mg tablets orally twice daily as the first actual treatment, then 12 mg orally twice daily as the first dose change. After the 12 mg dose was removed from the study, participants either discontinued or reverted to 8 mg'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID to CTP-543 8 mg BID', 'description': 'Participants received CTP-543 12 mg tablets orally, twice daily as the first actual treatment, then 8 mg orally, twice daily as the first dose change.'}], 'classes': [{'categories': [{'measurements': [{'value': '-96.38', 'spread': '8.790', 'groupId': 'OG000'}, {'value': '-88.57', 'spread': '18.715', 'groupId': 'OG001'}, {'value': '-90.25', 'spread': '18.860', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '108 weeks', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100\\*(post-baseline value - baseline)/baseline.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects received ≥1 dose of CTP-543 and ≥1 post-baseline SALT score. The 12 mg BID dose was removed per amended protocol; those on it were reduced to 8 mg BID and are shown in the (12→8 mg BID) group. Max 12 mg BID exposure was 81 weeks; by week 108, no subjects remained on it. Participant Flow reflects planned groups based on prior dose (active) or randomization (placebo). Analysis is based on initial treatment, then first new dose if changed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, twice a day'}, {'id': 'FG001', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, twice a day'}, {'id': 'BG001', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, twice a day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '12.41', 'groupId': 'BG000'}, {'value': '38.2', 'spread': '12.86', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '12.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '92', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '314', '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': '62', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-13', 'size': 3541934, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-17T13:49', 'hasProtocol': True}, {'date': '2024-08-14', 'size': 1276326, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-17T13:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2021-09-03', 'resultsFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-11', 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events as a Measure of Safety', 'timeFrame': '108 weeks'}, {'measure': 'Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108', 'timeFrame': '108 weeks', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100\\*(post-baseline value - baseline)/baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial\n\nExclusion Criteria:\n\n* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis\n* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication\n* Donation of blood at any point throughout the study and for 30 days after last dose of study medication'}, 'identificationModule': {'nctId': 'NCT05041803', 'briefTitle': 'European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata', 'orgStudyIdInfo': {'id': 'CP543.5002'}, 'secondaryIdInfos': [{'id': '2021-002365-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTP-543', 'description': 'Patients who previously completed a qualifying CTP-543 clinical trial', 'interventionNames': ['Drug: CTP-543']}], 'interventions': [{'name': 'CTP-543', 'type': 'DRUG', 'description': 'Twice daily dosing', 'armGroupLabels': ['CTP-543']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'state': 'Finistere', 'country': 'France', 'facility': 'Service de Dermatologie CHRU de Brest - 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