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

Phase 1

Recruiting

• Conditions: Vitiligo
• Interventions: Drug: FB102; Drug: Placebo

• Registration Number: NCT06905873
• Lead Sponsor: Forte Biosciences, Inc.

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 16 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.

Study Timeline

• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-24
• Study Start: 2025-03-25
• Status Verified: 2025-04
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-11-30
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 [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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FB102	FB102	Participants in this group will receive FB102.
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102	Upto 16 Weeks post first dose administration
Percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)	Upto 16 Weeks post first dose administration	The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)	Upto 16 Weeks post first dose administration	The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study

Secondary Outcome Measures

Name	Time	Method
Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline.	Upto 16 Weeks post first dose administration	The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
To evaluate the efficacy of FB102 compared to placebo by percent change from Baseline in total-Vitiligo Area Scoring Index (T-VASI)	Upto 16 Weeks post first dose administration	T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study

Trial Locations

Locations (8)

Skin & Cancer Foundation Australia - The Skin Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

Novatrials; 🇦🇺 Kotara, New South Wales, Australia

Cornerstone Dermatology; 🇦🇺 Coorparoo, Queensland, Australia

Veracity Clinical Research; 🇦🇺 Woolloongabba, Queensland, Australia

Optimal Clinical Trials North; 🇳🇿 Auckland, New Zealand

Optimal Clinical Trials Central; 🇳🇿 Auckland, New Zealand

Momentum Pukehoke; 🇳🇿 Auckland, New Zealand

PCRN Wellington; 🇳🇿 Wellington, New Zealand