RecruitingPhase 1NCT06905873

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


Sponsor

Forte Biosciences, Inc.

Enrollment

64 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria3

  • 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.

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Interventions

DRUGFB102

Route of administration- Intravenous (IV)

DRUGPlacebo

Route of administration- Intravenous (IV)


Locations(6)

Skin & Cancer Foundation Australia - The Skin Hospital

Darlinghurst, New South Wales, Australia

Novatrials

Kotara, New South Wales, Australia

Cornerstone Dermatology

Coorparoo, Queensland, Australia

Optimal Clinical Trials North

Auckland, Auckland, New Zealand

Optimal Clinical Trials Central

Auckland, Auckland, New Zealand

Momentum Pukehoke

Auckland, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT06905873


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