A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 16
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, ages 18 to 70 years
- •Diagnosis of plaque psoriasis for 6 months
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.
排除标准
- •Any significant acute or chronic medical illness
- •Blood transfusion within 4 weeks of study drug administration
- •Inability to tolerate oral medication
- •Positive hepatitis-B (HBV) surface antigen
- •Positive hepatitis-C (HCV) antibody
- •Any history or risk for tuberculosis (TB)
- •Any major illness/condition or evidence of an unstable clinical condition
- •Chest X-ray findings suspicious of infection at screening
- •has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication
- •Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication
- •Has received Rituximab within 6 months of first administration of study medication
- •Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
- •Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986165 Dose 1
Specified dose of BMS-986165 on specified days.
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 2
Specified dose of BMS-986165 on specified days.
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 3
Specified dose of BMS-986165 on specified days.
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 4
Specified dose of BMS-986165 on specified days.
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 5
Specified dose of BMS-986165 on specified days.
干预措施: BMS-986165 (Drug)
Placebo
Specified dose of Placebo for BMS-986165 on specified days.
干预措施: Placebo for BMS-986165 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Day 1 to day 115
The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
时间窗: Day 1 to Day 85
Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
次要结局
- Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.(Day 1 to Day 85)
- Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).(Day 1 to Day 85)
- Change From Baseline in DLQI Scores on Day 85(Day 1 to Day 85)
- Change From Baseline in BSA on Day 85(Day 1 to Day 85)
- Trough Observed Plasma Concentration of BMS-986165 (Ctrough)(Days 8, 15, 29, 57, 85)