NCT07190222招募中3 期
A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 942
- 试验地点
- 272
- 主要终点
- Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations
研究概览
简要总结
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.
Participation to the study consists of 3 periods:
- Screening period of up to 4 weeks
- Randomized intervention period of approximately 48 weeks
- Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
详细描述
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 40 to 80 years of age
- •Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
- •Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) <0.70
- •Former or current smokers ≥10 pack-years
- •Chronic Airways Assessment Test (CAAT) ≥10
- •≥2 moderate or ≥1 severe COPD exacerbations in the prior year
- •Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
- •EOS (blood eosinophil count) ≥ 150 cells/μL
- •18.0 ≤ Body Mass Index ≤ 40.0 kg/m2
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
- •Significant pulmonary disease other than COPD
- •Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min to maintain oxygen saturation >88% at rest
- •Unstable disorder that can impact participants safety or study outcomes
- •Active or incompletely treated tuberculosis
- •Current or past malignancies
- •Concomitant therapies:
- •long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for > 6 months
- •any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening
- •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
Placebo Comparator
Participants will receive lunsekimig-matching placebo.
干预措施: Placebo (Drug)
Lunsekimig dose regimen A
Experimental
Participants will receive lunsekimig dose regimen A.
干预措施: Lunsekimig (Drug)
Lunsekimig dose regimen B
Experimental
Participants will receive lunsekimig dose regimen B.
干预措施: Lunsekimig (Drug)
结局指标
主要结局
Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations
时间窗: From Baseline up to 48 weeks
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
次要结局
- Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)(From Baseline up to 48 weeks)
- Change from baseline in the SGRQ-C total score(From Baseline up to 48 weeks)
- SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score(From Baseline up to 48 weeks)
- Change from baseline in the Chronic airways assessment Test (CAAT) score(From Baseline up to 48 weeks)
- Change from baseline in the E-RS:COPD total score(From Baseline up to 48 weeks)
- Annualized rate of severe COPD exacerbations(From Baseline up to 48 weeks)
- Time to first moderate or severe COPD exacerbation(From Baseline up to 48 weeks)
- Time to first severe COPD exacerbation(From Baseline up to 48 weeks)
- Incidence of potentially clinically significant laboratory abnormalities(From Baseline up to 56 weeks)
- Serum concentration of lunsekimig(From Baseline up to 48 weeks)
- Incidence and titer of antidrug antibodies (ADAs)(From Baseline up to 48 weeks)
- Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)(From Baseline up to 48 weeks)
- CAAT responder defined as an improvement of ≥2 points in the CAAT total score(From Baseline up to 48 weeks)
- E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score(From Baseline up to 48 weeks)
- Incidence of participants with TEAEs, including AESIs, and SAEs(From Baseline up to 56 weeks)
研究者
研究点 (272)
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