A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT07205159
Intervention or treatment
DRUG: FB102
DRUG: Placebo
Conditions
- Alopecia Areata
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
St Leonards
Select from list below to view details:
St Leonards
Saint Leonards, New South Wales (nsw), Australia
Coorparoo
Coorparoo, Queensland, Australia
South Yarra
South Yarra, Victoria, Australia
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Who is running the clinical trial?
Forte Biosciences, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: FB102
| Drug: FB102 |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Not Specified | Upto 36 Weeks post first dose administration |
| Change from Baseline of Severity of Alopecia Tool (SALT) score at Week 16. | Not Specified | From Screening through Week 16. |
Secondary Outcome
References
Clinical Trials Gov: A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.Other trials to consider
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