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.
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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 is not well controlled. Participants will receive either lunsekimig or a placebo for about 48 weeks, followed by an 8-week follow-up.

Are You a Good Fit for This Trial?
Must be taking Triple (ICS+LABA+LAMA) therapy
Rules you out Active tuberculosis

You may be able to join if

  • I am between 40 to 80 years old
  • I have been diagnosed with COPD for at least 1 year
  • I have had 2 or more moderate or 1 severe COPD flare-ups in the past year
  • I have been on triple COPD therapy for at least 12 weeks
  • I have a blood eosinophil count of 150 cells/μL or higher
  • I have a body mass index 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 another significant lung disease besides COPD
  • I require long-term oxygen therapy of more than 4.0 L/min
  • I have unstable health issues that could affect my safety
  • I currently have or have had cancer
  • I have used certain medications within specific timeframes

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