jRCT2080225297已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis
Bristol-Myers Squibb1 个研究点目标入组 360 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, double-blind clinical trial
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 21age old over 至 No limit（—）
- 性别
- All
入选标准
- •IPF Cohort:
- •Diagnosis of IPF within 7 years
- •>=40 years of age
- •PF-ILD Cohort:
- •Evidence of progressive ILD within 24 months
- •>= 21 years of age
排除标准
- •Women who are of childbearing potential
- •Concurrent malignancy
结局指标
主要结局
-
efficacy
次要结局
- Evaluate AEs, SAEs, laboratory test results, etc. as safety(26 weeks)
- Evaluate the percent change in ppFCV in PF-ILD subjects(26 weeks)
- Evaluate PK parameters including Cmax, Tmax, and AUC of BMS-986278(Day1 and Week 4)
研究者
研究点 (1)
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