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

Official title

A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, 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

Overview

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

Interventions

• 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

Primary outcome measures

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

Secondary outcome measures (12)

• Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1) [Time frame: From Baseline up to 48 weeks]
• Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1) [Time frame: From Baseline up to 48 weeks]
• Change from baseline in the SGRQ-C total score [Time frame: From Baseline up to 48 weeks]
• SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score [Time frame: From Baseline up to 48 weeks]
• Change from baseline in the Chronic airways assessment Test (CAAT) score [Time frame: From Baseline up to 48 weeks]
• CAAT responder defined as an improvement of ≥2 points in the CAAT total score [Time frame: From Baseline up to 48 weeks]
• Change from baseline in the E-RS:COPD total score [Time frame: From Baseline up to 48 weeks]
• E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score [Time frame: From Baseline up to 48 weeks]
• Annualized rate of severe COPD exacerbations [Time frame: From Baseline up to 48 weeks]
• Time to first moderate or severe COPD exacerbation [Time frame: From Baseline up to 48 weeks]
• Time to first severe COPD exacerbation [Time frame: From Baseline up to 48 weeks]
• Incidence of participants with TEAEs, including AESIs, and SAEs [Time frame: From Baseline up to 56 weeks]

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 vital capacity) <0.70
• Former or current smokers ≥10 pack-years
• Chronic Airways Assessment Test (CAAT) ≥10
• ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
• Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
• EOS (blood eosinophil count) ≥ 150 cells/μL
• 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• 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
• Active or incompletely treated tuberculosis
• Current or past malignancies
• Concomitant therapies:

• long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for > 6 months
• any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 72 centers

Center list to be confirmed — check the primary protocol.

United States · 54 centers

• University of Alabama at Birmingham- Site Number : 8400003 — Birmingham
• Tucson Clinical Research Institute- Site Number : 8400006 — Tucson
• Inglewood Clinical- Site Number : 8400074 — Inglewood
• Ark Clinical Research- Site Number : 8400113 — Long Beach
• Alliance Clinical - West Hills- Site Number : 8400067 — Los Angeles
• California Medical Research Associates - Northridge- Site Number : 8400089 — Northridge
• Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005 — Boulder
• Critical Care Pulmonary & Sleep Associates- Site Number : 8400081 — Lakewood
• … and 46 more centers

Argentina · 12 centers

• Investigational Site Number : 0320011 — Berazategui
• Investigational Site Number : 0320004 — Buenos Aires
• Investigational Site Number : 0320002 — Buenos Aires
• Investigational Site Number : 0320005 — Buenos Aires
• Investigational Site Number : 0320006 — Buenos Aires
• Investigational Site Number : 0320001 — Buenos Aires
• Investigational Site Number : 0320012 — Buenos Aires
• Investigational Site Number : 0320003 — Buenos Aires
• … and 4 more centers

Canada · 11 centers

• Investigational Site Number : 1240051 — Kelowna
• Investigational Site Number : 1240052 — West Vancouver
• Investigational Site Number : 1240041 — Windsor
• … and 8 more centers

South Africa · 11 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 10 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 8 centers

Center list to be confirmed — check the primary protocol.

Chile · 7 centers

Center list to be confirmed — check the primary protocol.

South Korea · 7 centers

Center list to be confirmed — check the primary protocol.

Australia · 6 centers

• Investigational Site Number : 0360008 — Tiwi
• Investigational Site Number : 0360006 — South Brisbane
• Investigational Site Number : 0360004 — Townsville
• Investigational Site Number : 0360002 — Traralgon
• Investigational Site Number : 0360001 — Osborne Park
• Investigational Site Number : 5540004 — Dunedin

Malaysia · 6 centers

Center list to be confirmed — check the primary protocol.

Brazil · 5 centers

• Universidade Federal de Goias- Site Number : 0760002 — Goiânia
• Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004 — Belo Horizonte
• WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003 — Porto Alegre
• Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001 — São Bernardo do Campo
• IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005 — São Paulo

New Zealand · 3 centers

Center list to be confirmed — check the primary protocol.

Singapore · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07190222 · EFC18244 · 2024-518213-25-00 · U1111-1308-9980

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗