A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment 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
- 1,020
- 试验地点
- 198
- 主要终点
- The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
研究概览
简要总结
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.
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 or active comparator
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986165
BMS-986165 oral administration
干预措施: BMS-986165 (Drug)
Placebo
Placebo oral administration
干预措施: Placebo (Other)
Active comparator
Active comparator oral administration
干预措施: Apremilast (Drug)
结局指标
主要结局
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
时间窗: Week 16
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for 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). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
时间窗: Baseline and Week 16
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
次要结局
- The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)(Week 16)
- The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)(Baseline and Week 16)
- The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)(Baseline and Week 16)
- The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)(Week 16)
- Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16(Baseline and Week 16)
- Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16(Week 16)
- The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)(Week 16)
- The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)(Week 16)
- The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)(Week 16)
- The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)(Baseline and Week 16)
- The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)(Week 16)
- Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders(From Week 24 to Week 52 (up to approximately 28 weeks))
- The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)(Week 24)
- The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)(Baseline and Week 24)
- The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)(Baseline and week 24)