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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSanofi

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:

* 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lunsekimig
  • Placebo

Treatment groups

942 Participants
are divided into 3 treatment groups

Sponsors and collaborators