Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-25 @ 1:15 PM
Study NCT ID:
NCT07205159
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)', 'timeFrame': 'Upto 36 Weeks post first dose administration'}, {'measure': 'Change from Baseline of Severity of Alopecia Tool (SALT) score at Week 16.', 'timeFrame': 'From Screening through Week 16.', 'description': 'The Severity of Alopecia Tool (SALT) score ranges from 0 (no scalp hair loss) to 100 (complete scalp hair loss), with higher scores indicating greater severity. Change from baseline in SALT score at Week 16 will assess treatment effect. The AA-IGA categorizes SALT scores as follows: 0 = None (0%), 1 = Limited (1-20%), 2 = Moderate (21-49%), 3 = Severe (50-94%), 4 = Very Severe (95-100%).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of FB102 in patients with severe to very severe alopecia areata (AA).', 'detailedDescription': 'Up to approximately 32 participants who meet all the Screening eligibility criteria will be randomized in a 3:1 ratio to receive FB102, or placebo dosing to match.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 18-60 years and females aged 18-75 years at Screening.\n* Clinical diagnosis of severe to very severe AA with ≥50% scalp hair loss (including AT or AU) confirmed by SALT score and central photo review; no other cause of hair loss.\n\n * AT = complete scalp hair loss; AU = complete scalp, facial, and body hair loss. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria\n\nExclusion Criteria:\n\n* Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia).\n* Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis).\n* Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis, lichen planus, syphilis).\n\nNote: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria'}, 'identificationModule': {'nctId': 'NCT07205159', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forte Biosciences, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.', 'orgStudyIdInfo': {'id': 'FB102-701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FB102', 'description': 'Participants will receive FB102.', 'interventionNames': ['Drug: FB102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'FB102', 'type': 'DRUG', 'description': 'Route of administration- Intravenous (IV)', 'armGroupLabels': ['FB102']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Route of administration- Intravenous (IV)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2065', 'city': 'Saint Leonards', 'state': 'New South Wales (nsw)', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'St Leonards', 'geoPoint': {'lat': -38.17051, 'lon': 144.71803}}, {'zip': '4151', 'city': 'Coorparoo', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Coorparoo', 'geoPoint': {'lat': -27.49325, 'lon': 153.05826}}, {'zip': '3141', 'city': 'South Yarra', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'South Yarra', 'geoPoint': {'lat': -37.83834, 'lon': 144.99149}}, {'zip': '0632', 'city': 'Auckland', 'state': 'Auckland', 'status': 'NOT_YET_RECRUITING', 'country': 'New Zealand', 'facility': 'Auckland', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8013', 'city': 'Christchurch', 'state': 'Canterbury', 'status': 'NOT_YET_RECRUITING', 'country': 'New Zealand', 'facility': 'Christchurch', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '4414', 'city': 'Palmerston North', 'state': 'Palmerston North Central', 'status': 'NOT_YET_RECRUITING', 'country': 'New Zealand', 'facility': 'Palmerston North', 'geoPoint': {'lat': -40.35636, 'lon': 175.61113}}], 'centralContacts': [{'name': 'Support Officer', 'role': 'CONTACT', 'email': 'recruitment@clinibase.com', 'phone': '+61 3 7050 1941'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forte Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}