NCT06905873 A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
| NCT ID | NCT06905873 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Forte Biosciences, Inc. |
| Condition | Vitiligo |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria: 1. Males and females aged ≥ 18 to 75 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 \[a