Lunsekimig for Chronic Obstructive Pulmonary Disease

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

Recruiting Phase 3 Interventional Study
Chronic Obstructive Pulmonary Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
942 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for

This trial is looking for adults aged 40 to 80 with chronic obstructive pulmonary disease (COPD) that isn't well controlled. Participants will receive either lunsekimig or a placebo for approximately 48 weeks, followed by an 8-week follow-up.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 40 to 80 years old.
  • I have been diagnosed with chronic obstructive pulmonary disease (COPD) for at least 1 year.
  • I am a former or current smoker with at least 10 pack-years.
  • I have had at least 2 moderate or 1 severe COPD flare-ups in the past year.
  • I have been on triple therapy for COPD for at least 12 weeks.
  • My blood eosinophil count is at least 150 cells/μL.
  • My BMI is between 18.0 and 40.0 kg/m2.

You may not be able to join if

  • I have asthma or asthma-COPD overlap syndrome.
  • I have significant lung disease other than COPD.
  • I need long-term oxygen therapy of more than 4.0 L/min.
  • I have active or untreated tuberculosis.
  • I have had cancer in the past.
  • I am currently taking certain long-term medications like macrolides.
  • I have had any biologic therapy or systemic immunosuppressants in the last 4 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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: * …
Trial Locations
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Eligibility Criteria
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 vita…
Contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

contact-us@sanofi.com

CONTACT