A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 180
- 试验地点
- 151
- 主要终点
- Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy.
Study details include:
The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE.
The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE.
The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE.
For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant ≥1 year post bilateral lung transplantation at the time of screening
- •Participants presenting with CLAD Stage 1 or 2: FEV1 from >50% to 80% of post-transplant baseline at screening and at randomization
- •Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at least 3 times a week) prior to randomization
排除标准
- •FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4)
- •Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo + Azithromycin
Participants will receive placebo orally once daily
干预措施: Placebo (Drug)
Placebo + Azithromycin
Participants will receive placebo orally once daily
干预措施: Azithromycin (Drug)
Belumosudil + Azithromycin
Participants will receive 200 mg belumosudil orally once daily
干预措施: Belumosudil (Drug)
Belumosudil + Azithromycin
Participants will receive 200 mg belumosudil orally once daily
干预措施: Azithromycin (Drug)
结局指标
主要结局
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
时间窗: Baseline to Week 26
次要结局
- Response rate at Week 26(Baseline to Week 26)
- Absolute change from baseline to Week 26 in FEV1(Baseline to Week 26)
- Absolute change from baseline to Week 26 in percent predicted FEV1(Baseline to Week 26)
- Percent change from baseline to Week 26 in forced vital capacity (FVC)(Baseline to Week 26)
- Absolute change from baseline to Week 26 in FVC(Baseline to Week 26)
- Absolute change from baseline to Week 26 in percent predicted FVC(Baseline to Week 26)
- Time to CLAD progression during the double-blind treatment period(Baseline to Week 26)
- Percent change from baseline to Week 26 in 6-minute walk distance(Baseline to Week 26)
- Time to re-transplantation or death(Up to 7 days after the administration of last dose of study drug)
- Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1(Baseline to Week 26)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to 7 days after the administration of last dose of study drug)
- Absolute change from baseline to Week 26 in 6-minute walk distance(Baseline to Week 26)
- Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)(Baseline to Week 26)
- Change from baseline to Week 26 in EQ-5D-5L(Baseline to Week 26)