2023-503699-25-00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 Progressive Pulmonary Fibrosis
Bristol-Myers Squibb Services Unlimited Company113 个研究点 分布在 6 个国家目标入组 249 人开始时间: 2024年9月9日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 249
- 试验地点
- 113
- 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 2 doses of admilparant compared with placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52 in participants with PPF.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 21 years at the time of signing the informed consent.
- •Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
- •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.
- •Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
- •Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
- •Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK) (inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken 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
- •Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
- •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.
- •Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
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 (113)
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