A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.

Forte Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Alopecia Areata

Treatments: Drug: FB102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07205159

FB102-701

Details and patient eligibility

About

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).

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 2 patient groups, including a placebo group

FB102

Active Comparator group

Description:

Participants will receive FB102.

Treatment:

Drug: FB102

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo