FB102 treatment for adults 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.

This trial tests whether the medication FB102 can help adults with severe to very severe alopecia areata regrow hair and is safe compared with a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Forte Biosciences, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Saint Leonards, New South Wales (nsw) and 5 other locations)
• Trial ID: NCT07205159 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 trial enrolling up to approximately 32 participants with severe to very severe alopecia areata (≥50% scalp hair loss, including alopecia totalis or universalis). Participants will be randomized 3:1 to receive FB102 or placebo with matching dosing and undergo central photo review and SALT scoring to confirm eligibility and measure outcomes. The study focuses on safety and tolerability while collecting preliminary efficacy data on hair regrowth. Adult men and women meeting age and other inclusion/exclusion criteria attend scheduled visits at Australian trial sites for treatment and monitoring.

Who should consider this trial

Good fit: Adults who have severe to very severe alopecia areata with at least 50% scalp hair loss (including AT or AU), fall within the study age ranges, and have no other causes of hair loss are the intended participants.

Not a fit: People with other forms of hair loss, active scalp skin diseases, or systemic illnesses that cause hair loss are excluded and would not be expected to benefit from this study.

Why it matters

Potential benefit: If successful, FB102 could offer a new option to promote hair regrowth for people with severe to very severe alopecia areata.

How similar studies have performed: Other therapies that target immune pathways in alopecia areata, such as JAK inhibitors, have produced encouraging hair regrowth in severe cases, but FB102 itself is in early clinical testing and not yet proven.

Eligibility criteria

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.

  * 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

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).

Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria

Where this trial is running

Saint Leonards, New South Wales (nsw) and 5 other locations

• St Leonards — Saint Leonards, New South Wales (nsw), Australia (Not_yet_recruiting)
• Coorparoo — Coorparoo, Queensland, Australia (Recruiting)
• South Yarra — South Yarra, Victoria, Australia (Not_yet_recruiting)
• Auckland — Auckland, Auckland, New Zealand (Not_yet_recruiting)
• Christchurch — Christchurch, Canterbury, New Zealand (Not_yet_recruiting)
• Palmerston North — Palmerston North, Palmerston North Central, New Zealand (Not_yet_recruiting)

Study contacts

• Study coordinator: Support Officer

Conditions Alopecia Areata