Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
  • 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

Where this trial is running

• University of Alabama at Birmingham- Site Number : 8400003, Birmingham, Alabama, United States
• Tucson Clinical Research Institute- Site Number : 8400006, Tucson, Arizona, United States
• Inglewood Clinical- Site Number : 8400074, Inglewood, California, United States
• Ark Clinical Research- Site Number : 8400113, Long Beach, California, United States
• Alliance Clinical - West Hills- Site Number : 8400067, Los Angeles, California, United States
• California Medical Research Associates - Northridge- Site Number : 8400089, Northridge, California, United States
• Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005, Boulder, Colorado, United States
• Critical Care Pulmonary & Sleep Associates- Site Number : 8400081, Lakewood, Colorado, United States
• Howard University Hospital- Site Number : 8400080, Washington D.C., District of Columbia, United States
• Finlay Medical Research - Greenacres- Site Number : 8400107, Greenacres City, Florida, United States
• Direct Helpers Research Center- Site Number : 8400057, Hialeah, Florida, United States
• Pulmonary Specialists of the Palm Beaches- Site Number : 8400017, Loxahatchee Groves, Florida, United States

+ 201 more sites.

Who to contact

Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07190222.