A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Alopecia Areata
In brief
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).
Key facts
- Study ID
- NCT07205159
- Run by
- Forte Biosciences, Inc.
- People needed
- 32
- Starts
- 2025-10-23
- Expected to finish
- 2027-03-10
- Last updated by the study team
- 2025-11-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
- 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
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).
- Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
Where it is running
- Coorparoo — Coorparoo, Queensland, Australia (enrolling)
- St Leonards — Saint Leonards, New South Wales (nsw), Australia
- South Yarra — South Yarra, Victoria, Australia
- Auckland — Auckland, Auckland, New Zealand
- Christchurch — Christchurch, Canterbury, New Zealand
- Palmerston North — Palmerston North, Palmerston North Central, New Zealand
Full record on ClinicalTrials.gov
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