A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 31
- 主要终点
- The Percentage of Participants With sPGA Response of 0 or 1
研究概览
简要总结
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo in participants with moderate to severe plaque psoriasis in mainland China, Taiwan, and South Korea
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plaque psoriasis for at least 6 months
- •Moderate to severe disease
- •Candidate for phototherapy or systemic therapy
排除标准
- •Other forms of psoriasis
- •History of recent infection
- •Prior exposure to BMS-986165
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Arm A:BMS-986165 oral administration
干预措施: BMS-986165 (Drug)
Arm B: Placebo oral administration
干预措施: Placebo (Other)
结局指标
主要结局
The Percentage of Participants With sPGA Response of 0 or 1
时间窗: At week 16
static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 16 with at least a 2-point improvement from baseline. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score.
The Percentage of Participants With PASI 75 Response
时间窗: At week 16
Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment.
次要结局
- The Percentage of Participants With sPGA 0 Response(At week 16)
- The Percentage of Participants With PASI 100 Response(At week 16)
- The Percentage of Participants With Ss-PGA Score of 0 or 1(At week 16)
- The Percentage of Participants With PASI 75 Response at Week 52(At week 52)
- Change From Baseline in PSSD Symptom Score(Baseline and at Week 16)
- The Percentage of Participants With Pp-PGA Score of 0 or 1(At week 16)
- The Percentage of Participants With PASI 90 Response(At week 16)
- The Percentage of Participants With DLQI Score of 0 or 1(At week 16)
- The Percentage of Participants With sPGA Response of 0 or 1 at Week 52(At week 52)
- The Percentage of Participants With PGA-F Score of 0 or 1(At week 16)
- The Percentage of Participants With PSSD Symptom Score of 0(At week 16)