Lunsekimig versus placebo for eosinophilic COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel Phase 2b/Phase 3, three-arm trial comparing subcutaneous lunsekimig with matching placebo during a 48-week treatment period followed by an ~8-week follow-up. Eligible participants undergo screening of up to 4 weeks, are randomized to receive study drug or placebo, and continue regular study visits for dosing and safety assessments over about 60 weeks total. The study enrolls adults with an eosinophilic COPD phenotype who remain symptomatic despite triple inhaled therapy, and it measures efficacy, safety, and tolerability outcomes. All participants receive subcutaneous administrations during the intervention period and are monitored for exacerbations, lung function, and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

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.

Where it's running

• University of Alabama at Birmingham- Site Number : 8400003
  Birmingham, Alabama, United States Recruiting
• Pulmonary Associates - Mobile- Site Number : 8400151
  Mobile, Alabama, United States Recruiting
• Tucson Clinical Research Institute- Site Number : 8400006
  Tucson, Arizona, United States Recruiting
• Ark Clinical Research- Site Number : 8400113
  Long Beach, California, United States Recruiting
• Inglewood Clinical- Site Number : 8400074
  Los Angeles, California, United States Recruiting
• Alliance Clinical - West Hills- Site Number : 8400067
  Los Angeles, California, United States Recruiting

+264 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.