Status:
RECRUITING
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
Lead Sponsor:
Forte Biosciences, Inc.
Conditions:
Vitiligo
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.
Detailed Description
Approximately 64 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.
Eligibility Criteria
Inclusion
- Males and females aged ≥ 18 to 75 years at time of Screening.
- Must have confirmed non-segmental vitiligo criteria at the Screening Visit and the Baseline Visit, as assessed by the study investigator.
- If receiving concomitant medications for any reason other than vitiligo, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.
- Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria
Exclusion
- Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorders including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditaria, xeroderma pigmentosum, and nevus depigmentosus).
- Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (including but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Day 1 Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.
- Greater than approximately 33% leukotrichia (depigmentation of the hair) in areas of vitiligo on the face as assessed by a healthcare professional at the time of screening.
- Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06905873
Start Date
March 25 2025
End Date
December 31 2026
Last Update
November 20 2025
Active Locations (6)
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1
Skin & Cancer Foundation Australia - The Skin Hospital
Darlinghurst, New South Wales, Australia, 2010
2
Novatrials
Kotara, New South Wales, Australia, 2289
3
Cornerstone Dermatology
Coorparoo, Queensland, Australia, 4151
4
Optimal Clinical Trials North
Auckland, Auckland, New Zealand, 0632