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
NCT07190222 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 942
Last updated 2026-05-08
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.
Conditions
Interventions
- DRUG
-
Lunsekimig
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
- DRUG
-
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-17
- Primary Completion
- 2029-11-27
- Completion
- 2030-01-22
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Brazil
- Canada
- Chile
- China
- Malaysia
- New Zealand
- Singapore
- South Africa
- South Korea
- Taiwan
- United Kingdom
Study Locations
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