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

Last updated: April 21, 2025
Sponsor: Forte Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Vitiligo

Treatment

FB102

Placebo

Clinical Study ID

NCT06905873
FB102-401
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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 theBaseline Visit, as assessed by the study investigator.

  3. If receiving concomitant medications for any reason other than vitiligo, must be ona stable regimen, which is defined as not starting a new drug or changing dosagewithin 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant mustbe 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

Exclusion Criteria:

  1. Currently have active forms of other hypopigmentation (including but not limited toVogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation [melanoma andmycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [minormanifestation of atopic dermatitis], senile leukoderma [age-related depigmentation],chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis,melasma, and congenital hypopigmentation disorders including piebaldism, Waardenburgsyndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetricahereditaria, xeroderma pigmentosum, and nevus depigmentosus).

  2. Currently have active forms of inflammatory skin disease(s) or evidence of skinconditions (including but not limited to morphea, discoid lupus, leprosy, syphilis,psoriasis, seborrheic dermatitis) at the time of the Screening or Day 1 Visit thatin the opinion of the investigator would interfere with evaluation of vitiligo orresponse to treatment.

  3. Greater than approximately 33% leukotrichia (depigmentation of the hair) in areas ofvitiligo on the face as assessed by a healthcare professional at the time ofscreening.

Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: FB102
Phase: 1
Study Start date:
March 25, 2025
Estimated Completion Date:
January 31, 2026

Study Description

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

Connect with a study center

  • Skin & Cancer Foundation Australia - The Skin Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Novatrials

    Kotara, New South Wales 2289
    Australia

    Active - Recruiting

  • Cornerstone Dermatology

    Coorparoo, Queensland 4151
    Australia

    Active - Recruiting

  • Veracity Clinical Research

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Momentum Pukehoke

    Auckland, 2120
    New Zealand

    Active - Recruiting

  • Optimal Clinical Trials Central

    Auckland, 1010
    New Zealand

    Active - Recruiting

  • Optimal Clinical Trials North

    Auckland, 0632
    New Zealand

    Active - Recruiting

  • PCRN Wellington

    Wellington, 5018
    New Zealand

    Site Not Available

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