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

NCT06905873 | Recruiting Phase 1 DMC

• 1 other identifier: FB102-401
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 6

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  Upto 16 Weeks post first dose administration

• Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)

  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

  Upto 16 Weeks post first dose administration

Secondary Outcomes (2)

• Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline.

  Upto 16 Weeks post first dose administration

• 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

Study Arms (2)

FB102

ACTIVE COMPARATOR

Participants in this group will receive FB102.

Drug: FB102

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

FB102 DRUG

Route of administration- Intravenous (IV)

FB102

Placebo DRUG

Route of administration- Intravenous (IV)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forte Biosciences, Inc.: lead

Study Sites (6)

Skin & Cancer Foundation Australia - The Skin Hospital

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Novatrials

Kotara, New South Wales, 2289, Australia

RECRUITING

Cornerstone Dermatology

Coorparoo, Queensland, 4151, Australia

RECRUITING

Optimal Clinical Trials North

Auckland, Auckland, 0632, New Zealand

RECRUITING

Optimal Clinical Trials Central

Auckland, Auckland, 1010, New Zealand

RECRUITING

Momentum Pukehoke

Auckland, Auckland, 2120, New Zealand

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 2, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (3); AU (3)