A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants 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
- 120
- 试验地点
- 35
- 主要终点
- Percentage of Participants Achiving PASI-75 at Week 12
研究概览
简要总结
The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plaque psoriasis (PsO) for ≥ 6 months
- •Body mass index 18 to 40 kg/m^2 and total body weight > 50 kg (110 lbs)
- •Deemed by Investigator to be eligible for phototherapy or systemic therapy
- •Psoriatic plaques must cover ≥ 10% of body surface area at baseline
- •Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global Assessment (sPGA) ≥ 3 at baseline
排除标准
- •Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic)
- •Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment
- •Any significant acute or chronic medical illness
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986322 Dose 1
干预措施: BMS-986322 (Drug)
BMS-986322 Dose 2
干预措施: BMS-986322 (Drug)
BMS-986322 Dose 3
干预措施: BMS-986322 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Achiving PASI-75 at Week 12
时间窗: 12 Weeks
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), 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-75 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 75% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Number of Participants With Safety Related Events
时间窗: approximately 85 days
Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events.
Number of Participants With TEAE by Worst Intensity
时间窗: approximately 5 months
Mild TEAE: An event that is easily tolerated by the participant, causing minimal discomfort, and not interfering with everyday activities. Moderate TEAE:An event that causes sufficient discomfort and interferes with normal everyday activities. Severe TEAE: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.
Number of Participants With AE Indicating Clinical Laboratory Abnormality
时间窗: approximately 5 months
Number of participants with AE indicating clinical laboratory abnormality
Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations.
时间窗: approximately 5 months
Number of participants with clinically significant changes from baseline in ECG evaluations. ECG results for participants with any result outside of a pre-specified range and investigator identified abnormalities will be listed for the Safety Population. The following criteria will be used to determine ECG results that are outside of a pre-specified range: * PR (msec): Value \> 200 * QRS (msec): Value \> 120 * QT (msec): Value \> 500 or change from baseline \> 30 * QTcF (msec): Value \> 450 or change from baseline \> 30
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations
时间窗: approximately 5 months
Number of participants with clinically significant changes from baseline in vital signs evaluations. Vital signs for participants with any out-of-range result will be listed for the Safety Population. The following criteria will be used to determine vital sign results that are outside of a prespecified range, where changes from baseline are based on matched postural positions: * Heart Rate (bpm): Value \> 100 and change from baseline \> 30, or Value \< 55 and change from baseline \< -15 * Systolic blood pressure (mmHg): Value \> 140 and change from baseline \> 20, or Value \< 90 and change from baseline \< -20 * Diastolic blood pressure (mmHg): Value \> 90 and change from baseline \> 10, or Value \< 55 and change from baseline \< -10 * Respiration (breaths/min): Value \> 16 or change from baseline \> 10 * Temperature (°C): Value \> 38.3 or change from baseline \> 1.6
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations
时间窗: approximately 5 months
Number of participants with clinically significant changes from baseline in physical examination evaluations
次要结局
- Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12(12 Weeks)
- Percentage of Participants Achiving PASI-90 at Week 12(12 Weeks)
- Percentage of Participants Achiving PASI-100 at Week 12(12 Weeks)
- Tmax at Day 15(At Day 15 post first dose)
- Percentage of Participants Achiving PASI-50 at Week 12(12 Weeks)
- Change of PASI-75 Scores Overtime(From start of treatment (Week 1) to Week 2, 4, 8 and 12)
- Change of PASI-90 Scores Overtime(From start of treatment (Week 1) to Week 2, 4, 8 and 12)
- Change of PASI-100 Scores Overtime(From start of treatment (Week 1) to Week 2, 4, 8 and 12)
- Change of PASI-50 Scores Overtime(From start of treatment (Week 1) to Week 2, 4, 8 and 12)
- Mean Change Frome Baseline of PASI Scores Overtime(From start of treatment (Week 1) to Week 2, 4, 8, and 12)
- Ctrough Measurements Overtime(From start of treatment (Week 1) to Week 2, 4, 8 and 12)
- Cmax at Day 15(At Day 15 post first dose)
- AUC(Tau) at Day 15(At Day 15 post first dose)