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

Forte Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Vitiligo

Treatments: Drug: FB102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06905873

FB102-401

Details and patient eligibility

About

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

Full description

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

FB102

Active Comparator group

Description:

Participants in this group will receive FB102.

Treatment:

Drug: FB102

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo