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

A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-Segmental Vitiligo

A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: FB102; Drug: Placebo

Detailed Description

Approximately 64 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • Skin & Cancer Foundation Australia - The Skin Hospital
      • Contact: Cindy Kok; Phone Number: +61 2 8651 2042; Email: ckok@skinhospital.edu.au
    • Kotara, New South Wales, Australia, 2289
      • Recruiting
      • Novatrials
      • Contact: Georgia Hallett; Phone Number: +61 2 4058 5486; Email: georgia@novatrials.com.au
  • Queensland
    • Coorparoo, Queensland, Australia, 4151
      • Recruiting
      • Cornerstone Dermatology
      • Contact: Margaret Anders; Phone Number: +61 7 3397 3200; Email: Margaretjanders@gmail.com
• New Zealand
  • Auckland
    • Auckland, Auckland, New Zealand, 0632
      • Recruiting
      • Optimal Clinical Trials North
      • Contact: Claudette Lionnet; Phone Number: 64212178639; Email: claudette@optimalclinicaltrials.com
    • Auckland, Auckland, New Zealand, 1010
      • Recruiting
      • Optimal Clinical Trials Central
      • Contact: Olu De Rozario; Phone Number: 0800 73 73 27; Email: Olu@optimalclinicaltrials.com
    • Auckland, Auckland, New Zealand, 2120
      • Recruiting
      • Momentum Pukehoke
      • Contact: Michelle Baker; Phone Number: +640508919919; Email: michelle@nzrsi.health.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Route of administration- Intravenous (IV)
Active Comparator: FB102; Participants in this group will receive FB102.	Drug: FB102; Route of administration- Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline.	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
To evaluate the efficacy of FB102 compared to placebo by percent change from Baseline in total-Vitiligo Area Scoring Index (T-VASI)	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	Upto 16 Weeks post first dose administration

Collaborators and Investigators

• Sponsor: Forte Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo
• Other Study ID Numbers: FB102-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No