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

Conditions

• Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Lunsekimig — DRUG
  Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
• Placebo — DRUG
  Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection

Study Details

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.

Key Dates

Start date

Sep 16, 2025

Status verified

Jun 2026

Primary completion

Nov 27, 2029

Completion

Jan 22, 2030

Study Design

Enrollment

942 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lunsekimig dose regimen A
  Participants will receive lunsekimig dose regimen A.
• Experimental: Lunsekimig dose regimen B
  Participants will receive lunsekimig dose regimen B
• Placebo Comparator: Placebo
  Participants will receive lunsekimig-matching placebo

Primary Outcome Measure

Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: From Baseline up to 48 weeks ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (66)

Find similar trials in Chandler, AZ

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