NCT07205159 A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
| NCT ID | NCT07205159 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Forte Biosciences, Inc. |
| Condition | Alopecia Areata |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-03-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2025-10-23 with a primary completion date of 2027-03-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07205159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Alopecia Areata. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07205159 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07205159 currently recruiting?
Yes, NCT07205159 is actively recruiting participants. Contact the research team at recruitment@clinibase.com for enrollment information.
Where is the NCT07205159 trial being conducted?
This trial is being conducted at Saint Leonards, Australia, Coorparoo, Australia, South Yarra, Australia, Auckland, New Zealand and 2 additional locations.
Who is sponsoring the NCT07205159 clinical trial?
NCT07205159 is sponsored by Forte Biosciences, Inc.. The trial plans to enroll 32 participants.