Lunsekimig versus placebo for inadequately controlled 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 3-arm Phase 2b/3 trial comparing subcutaneous lunsekimig to matching placebo over a 48-week treatment period with an additional screening and 8-week follow-up for a total study time up to about 60 weeks. Eligible participants have physician-diagnosed COPD for at least one year, a blood eosinophil count ≥150 cells/µL, persistent symptoms and recent exacerbations despite ICS+LABA+LAMA therapy, and meet standard spirometric criteria. Participants receive scheduled subcutaneous doses of lunsekimig or placebo and are monitored for exacerbations, lung function, symptoms, safety, and tolerability throughout the treatment period. The trial collects safety and efficacy data to determine whether lunsekimig provides clinical benefit in this eosinophilic COPD subgroup.

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

• Chandler Clinical Research Trials- Site Number : 8400025
  Chandler, Arizona, United States Recruiting
• Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
  Phoenix, Arizona, United States Recruiting
• Epic Medical Research - Surprise- Site Number : 8400096
  Surprise, Arizona, United States Recruiting
• IMAX Clinical Trials- Site Number : 8400109
  La Palma, California, United States Recruiting
• Long Beach Research Institute- Site Number : 8400027
  Long Beach, California, United States Recruiting
• Downtown L.A. Research Center- Site Number : 8400009
  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.