A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
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.
1 other identifier
interventional
32
2 countries
6
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2025
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedStudy Start
First participant enrolled
October 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 10, 2027
November 20, 2025
November 1, 2025
1.4 years
September 25, 2025
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Upto 36 Weeks post first dose administration
Change from Baseline of Severity of Alopecia Tool (SALT) score at Week 16.
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%).
From Screening through Week 16.
Study Arms (2)
FB102
ACTIVE COMPARATORParticipants will receive FB102.
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Males aged 18-60 years and females aged 18-75 years at Screening.
- 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.
You may not qualify if:
- Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia).
- Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis).
- Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis, lichen planus, syphilis).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
St Leonards
Saint Leonards, New South Wales (nsw), 2065, Australia
Coorparoo
Coorparoo, Queensland, 4151, Australia
South Yarra
South Yarra, Victoria, 3141, Australia
Auckland
Auckland, Auckland, 0632, New Zealand
Christchurch
Christchurch, Canterbury, 8013, New Zealand
Palmerston North
Palmerston North, Palmerston North Central, 4414, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2025
First Posted
October 3, 2025
Study Start
October 23, 2025
Primary Completion (Estimated)
March 10, 2027
Study Completion (Estimated)
March 10, 2027
Last Updated
November 20, 2025
Record last verified: 2025-11