Clinical trial NCT06905873: A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
Official title: A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-Segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Vitiligo
Lead sponsor: Forte Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

1. Males and females aged ≥ 18 to 65 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

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102
timeFrame: Upto 16 Weeks post first dose administration
measure: Percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
timeFrame: Upto 16 Weeks post first dose administration
measure: Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
timeFrame: Upto 16 Weeks post first dose administration
Secondary outcomes:
measure: Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline.
timeFrame: Upto 16 Weeks post first dose administration
measure: To evaluate the efficacy of FB102 compared to placebo by percent change from Baseline in total-Vitiligo Area Scoring Index (T-VASI)
timeFrame: Upto 16 Weeks post first dose administration
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Skin & Cancer Foundation Australia - The Skin Hospital
state: New South Wales
city: Kotara
country: Australia
facility: Novatrials
state: New South Wales
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials North
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials Central
city: Auckland
country: New Zealand
facility: Momentum Pukehoke
city: Wellington
country: New Zealand
facility: PCRN Wellington
Study officials:
References: