An Extension Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig, Including Inhaled Corticosteroid Withdrawal, in Adults With Chronic Obstructive Pulmonary Disease (COPD) Who Completed Studies EFC18243 or EFC18244
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Sanofi
- 入组人数
- 1,508
- 主要终点
- Exposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE)
研究概览
简要总结
This is an open-label, Phase 3, long-term safety extension study including participants of previous lunsekimig clinical trials with inadequately controlled chronic obstructive pulmonary disease (COPD ) characterized by an eosinophilic phenotype.
The purpose of the LTS 18211 study is to characterize the long-term safety and efficacy of lunsekimig in adults with COPD who completed studies EFC18243 or EFC18244 in the main study, and to assess the impact of inhaled corticosteroids (ICS ) withdrawal in the ICS withdrawal sub-study.
The study duration will be up to 100 weeks, including the following components:
- Baseline Visit (Visit 1 / Week 0) will coincide with the End-of-Intervention visit from the parent study (EFC18243 or EFC18244) if possible
- Treatment duration of up to 96 weeks
- Safety follow-up period of approximately 4 weeks
- The number of visits will be 26
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who completed the treatment period of EFC18243 or EFC18244 studies, including EOI visit
- •Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And:
- •Female participants: not pregnant or breastfeeding, and one of the following conditions applies:
- •Is not a women of childbearing potential (WOCBP), OR
- •Is a WOCBP and agrees to follow the contraceptive guidance. The WOCBP should also agree not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction.
- •Male participants: No sperm donation or cryopreserving sperm
- •ICS-withdrawal sub-study only:
- •Participants receiving triple controller therapy (LABA+LAMA+ICS)
- •Participants who were compliant with lunsekimig
- •≤ 1 moderate exacerbation and no severe exacerbation of COPD during the parent study
- •No exacerbation during the run-in period
排除标准
- •The exclusion criteria are identical for LTS18211 and ICS withdrawal sub-study:
- •Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement, would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participant potentially at risk of noncompliance to study procedures
- •Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- •History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- •Participants who are receiving prohibited concomitant medications at LTS18211 baseline
- •Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, and for whom continuation of treatment with lunsekimig may present an unreasonable risk
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Lunsekimig sub-study with ICS maintenance
ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to maintain the same inhaled regimen
干预措施: Lunsekimig (Drug)
Lunsekimig core study
Subcutaneous (SC) administration of lunsekimig for up to 96 weeks, with the same inhaled controller medication as in the parent study (LABA + LAMA + ICS or LABA + LAMA)
干预措施: Lunsekimig (Drug)
Lunsekimig sub-study with ICS withdrawal
ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to withdraw ICS
干预措施: Lunsekimig (Drug)
结局指标
主要结局
Exposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE)
时间窗: Study baseline to Week 100
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
ICS withdrawal sub-study: Change from Week 12 (end of run-in period) to Week 36 in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)
时间窗: From Week 12 to Week 36
次要结局
- Change from parent study baseline in pre-BD FEV1(Parent study baseline to Weeks 48 and 96)
- Annualized rate of moderate-to-severe COPD exacerbations(Study baseline to Week 96)
- Change from parent study baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)(Parent study baseline to Weeks 48 and 96)
- Change from parent study baseline in SGRQ-C total score(Parent study baseline to Weeks 48 and 96)
- ICS withdrawal sub-study: Time to first moderate or severe AECOPD(From Week 12 to Week 96)
- ICS withdrawal sub-study: Change from Week 12 to Week 36 in SGRQ-C total score(From Week 12 to Week 36)