A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-Segmental Vitiligo
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102
研究概览
简要总结
A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.
详细描述
Approximately 64 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
- •Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
研究组 & 干预措施
FB102
Participants in this group will receive FB102.
干预措施: FB102 (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102
时间窗: Upto 16 Weeks post first dose administration
Percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
时间窗: Upto 16 Weeks post first dose administration
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
Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
时间窗: Upto 16 Weeks post first dose administration
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
次要结局
- Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline.(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)(Upto 16 Weeks post first dose administration)