2023-503697-21-01招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis
Bristol-Myers Squibb Services Unlimited Company114 个研究点 分布在 10 个国家目标入组 239 人开始时间: 2024年8月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 239
- 试验地点
- 114
- 主要终点
- Absolute change in FVC (mL) from baseline at Week 52.
研究概览
简要总结
To evaluate the efficacy of admilparant compared to placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
- •Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
- •If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
- •If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
- •Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test at screening and predose
- •Men who are sexually active with women of childbearing potential agree to use male barrier contraception
排除标准
- •History of stroke or transient ischemic attack within 3 months prior to screening.
- •Exhibit symptoms of heart failure at rest
- •Participants who have: 1) a current malignancy, 2) a previous malignancy with less than 2 years free of recurrence; 3) a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be ruled out.
- •Interstitial Lung Disease (ILD) associated with known primary causes (eg.hypersensitivity pneumonitis,autoimmune associated ILD,sarcoidosis,etc.)
研究组 & 干预措施
Placebo for BMS-986278
Placebo
干预措施: Placebo for BMS-986278 (Drug)
LPA1 antagonist, LPA1 antagonist
Test
干预措施: LPA1 antagonist (Drug)
结局指标
主要结局
Absolute change in FVC (mL) from baseline at Week 52.
Absolute change in FVC (mL) from baseline at Week 52.
次要结局
- Disease progression 4-component composite endpoint: Time to first disease progression event from Day 1 through the Primary Endpoint Visit.
- Change in walking distance measured in 6MWT from baseline at Week 52
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (114)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis2023-503699-25-00Bristol-Myers Squibb Services Unlimited Company249
招募中
3 期
A Study to Test the Effectiveness and Safety of RO7790121 for induction and maintenance therapy in Patients with Moderately to Severely Active Crohn's Disease2024-513053-69-00F. Hoffmann-La Roche AG348
招募中
3 期
Study to assess the efficacy and safety of adjunctive NBI-1065845 in adults with Major Depressive Disorder (MDD)Major Depressive Disorder2024-519421-37-00Neurocrine Biosciences Inc.55
招募中
3 期
A Study to Assess the Effectiveness and Safety of RO7790121 for Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis2024-513014-35-00F. Hoffmann-La Roche AG348
招募中
2 期
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive DyskinesiaTardive DyskinesiaNCT07365462Neurocrine Biosciences100