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Clinical Trial NCT07205159 for Alopecia Areata is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. Phase 1 32 Randomized Double-Blind Placebo-Controlled

Recruiting
Clinical Trial NCT07205159 is designed to study Treatment for Alopecia Areata. It is a Phase 1 interventional study that is recruiting, having started on 23 October 2025, with plans to enroll 32 participants. Led by Forte Biosciences, Inc., it is expected to complete by 10 March 2027. The latest data from ClinicalTrials.gov was last updated on 20 November 2025.
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).
Detailed Description
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.
Official Title

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.

Conditions
Alopecia Areata
Other Study IDs
  • FB102-701
NCT ID Number
NCT07205159
Start Date (Actual)
2025-10-23
Last Update Posted
2025-11-20
Completion Date (Estimated)
2027-03-10
Enrollment (Estimated)
32
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorFB102
Participants will receive FB102.
FB102
Route of administration- Intravenous (IV)
Placebo ComparatorPlacebo
Matching placebo
Placebo
Route of administration- Intravenous (IV)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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

  • 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

Forte Biosciences, Inc. logoForte Biosciences, Inc.
Study Central Contact
Contact: Support Officer, +61 3 7050 1941, [email protected]
6 Study Locations in 2 Countries

New South Wales (nsw)

St Leonards, Saint Leonards, New South Wales (nsw), 2065, Australia
Not yet recruiting

Queensland

Coorparoo, Coorparoo, Queensland, 4151, Australia
Recruiting

Victoria

South Yarra, South Yarra, Victoria, 3141, Australia
Not yet recruiting

Auckland

Auckland, Auckland, Auckland, 0632, New Zealand
Not yet recruiting

Canterbury

Christchurch, Christchurch, Canterbury, 8013, New Zealand
Not yet recruiting

Palmerston North Central

Palmerston North, Palmerston North, Palmerston North Central, 4414, New Zealand
Not yet recruiting