A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo

Launched by FORTE BIOSCIENCES, INC. · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called FB102 for people with non-segmental vitiligo, a skin condition where patches of skin lose their color. The study aims to find out how safe and effective FB102 is compared to a placebo, which is a treatment without the active drug. The trial is in its early phase and has not started recruiting participants yet. It will involve both men and women aged 18 to 75 who have been diagnosed with non-segmental vitiligo.

To participate, individuals must meet certain criteria; they should not have any other active skin conditions that could interfere with the study. Participants must also be stable on any other medications they take for at least a week before the study starts. If you join the trial, you will be randomly assigned to receive either FB102 or a placebo, and you won't know which one you're getting. This helps researchers understand how well the treatment works. If you're considering participating, the study center will provide more details and check if you meet all the necessary criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females aged ≥ 18 to 65 years at time of Screening.
• • 2. Must have confirmed non-segmental vitiligo criteria at the Screening Visit and the Baseline Visit, as assessed by the study investigator.
• • 3. 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 Criteria:
• • 1. 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).
• • 2. 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.
• • 3. 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