Evaluating FB102 for treating 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

This study is testing a new treatment called FB102 to see if it can help people with non-segmental vitiligo improve their skin condition.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Forte Biosciences, Inc. (industry)
• Locations: 6 sites (Darlinghurst, New South Wales and 5 other locations)
• Trial ID: NCT06905873 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of FB102 in patients diagnosed with non-segmental vitiligo. Approximately 16 participants will be randomly assigned to receive either FB102 or a placebo in a double-blind manner. The study aims to assess the treatment's effects over a specified period while ensuring participants meet strict eligibility criteria. Participants must be stable on any concomitant medications and will be monitored closely throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 75 with confirmed non-segmental vitiligo.

Not a fit: Patients with active forms of other hypopigmentation or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from non-segmental vitiligo.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating skin conditions, but specific outcomes for FB102 are yet to be established.

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 \[age-related depigmentation\], 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

Where this trial is running

Darlinghurst, New South Wales and 5 other locations

• Skin & Cancer Foundation Australia - The Skin Hospital — Darlinghurst, New South Wales, Australia (RECRUITING)
• Novatrials — Kotara, New South Wales, Australia (RECRUITING)
• Cornerstone Dermatology — Coorparoo, Queensland, Australia (RECRUITING)
• Optimal Clinical Trials North — Auckland, Auckland, New Zealand (RECRUITING)
• Optimal Clinical Trials Central — Auckland, Auckland, New Zealand (RECRUITING)
• Momentum Pukehoke — Auckland, Auckland, New Zealand (RECRUITING)

Conditions: Vitiligo