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.
Study details:
Approximately 16 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Males and females aged ≥ 18 to 65 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 criteria
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06905873
Intervention or treatment
DRUG: FB102
DRUG: Placebo
Conditions
- Vitiligo
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Skin & Cancer Foundation Australia - The Skin Hospital
Select from list below to view details:
Skin & Cancer Foundation Australia - The Skin Hospital
Darlinghurst, New South Wales, Australia
Novatrials
Kotara, New South Wales, Australia
Cornerstone Dermatology
Coorparoo, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
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Who is running the clinical trial?
Forte Biosciences, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: FB102
| Drug: FB102 |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102 | Not Specified | Upto 16 Weeks post first dose administration |
| Percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI) | The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
| Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI) | The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline. | The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
| To evaluate the efficacy of FB102 compared to placebo by percent change from Baseline in total-Vitiligo Area Scoring Index (T-VASI) | T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study | Upto 16 Weeks post first dose administration |
References
Clinical Trials Gov: A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental VitiligoOther trials to consider
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