A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 31
- 主要终点
- Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blinded
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
- •Clinical diagnosis of nonsegmental vitiligo.
- •History of prior vitiligo treatment with a total duration of at least 3 months.
- •Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
- •Willingness to avoid pregnancy or fathering children
- •Further inclusion criteria apply.
排除标准
- •Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.
- •Uncontrolled thyroid function at screening as determined by the investigator.
- •Women who are pregnant (or who are considering pregnancy) or lactating.
- •Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- •Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- •Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
- •Laboratory values outside of the protocol-defined ranges.
- •Further exclusion criteria apply.
研究组 & 干预措施
INCB054707 Dose A followed by Dose C
Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
干预措施: INCB054707 (Drug)
INCB054707 Dose B
Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).
干预措施: INCB054707 (Drug)
INCB054707 Dose C
Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).
干预措施: INCB054707 (Drug)
Placebo followed by INCB054707 Dose C
Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
时间窗: Baseline; Week 24
The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area \[BSA\]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100.
次要结局
- Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to Week 24)
- Extension Period: Number of Participants With Any TEAE(from Week 25 up to Week 76)
- Percentage of Participants Achieving T-VASI50 at Week 24(Baseline; Week 24)