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
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 主要终点
- PASI-75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 70age old under（—）
- 性别
- All
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.
结局指标
主要结局
PASI-75
时间窗: At week 12
Proportion of participants achieving 75% reduction in PASI score
TEAEs
时间窗: Up to 16 weeks
Number of participants with treatment-emergent adverse event
SAEs
时间窗: Up to 16 weeks
Number of participants with serious adverse events
TEAEs leading to treatment discontinuation
时间窗: Up to 16 weeks
Number of participants with TEAEs leading to treatment discontinuation
Clinical laboratory abnormalities
时间窗: Up to 16 weeks
Number of participants with clinical laboratory abnormalities
ECG abnormalities
时间窗: Up to 16 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Vital sign abnormalities
时间窗: Up to 16 weeks
Number of participants with vital sign abnormalities
Physical examination abnormalities
时间窗: Up to 16 weeks
Number of participants with physical examination abnormalities
次要结局
- sPGA score of 0 or 1(At week 12)
- PASI-50(At week 12)
- PASI-90(At week 12)
- PASI-100(At week 12)
- PASI-50 (up to week 12)(Up to week 12)
- PASI-75(Up to week 12)
- PASI-90 (up to week 12)(Up to week 12)
- PASI-100 (up to week 12)(Up to week 12)
- Change from baseline in PASI score(Up to week 12)
- BMS-986322 trough concentrations(Up to week 12)
- Cmax of BMS-986322(At day 15)
- AUC(TAU) of BMS-986322(At day 15)
- Tmax of BMS-986322(At day 15)