Trials / Recruiting
RecruitingNCT07190209
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
A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 942 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lunsekimig | Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection |
| DRUG | Placebo | Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection |
Timeline
- Start date
- 2025-09-16
- Primary completion
- 2029-11-27
- Completion
- 2030-01-22
- First posted
- 2025-09-24
- Last updated
- 2026-03-23
Locations
153 sites across 9 countries: United States, Argentina, Brazil, Canada, Chile, China, Japan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07190209. Inclusion in this directory is not an endorsement.