Recruiting NCT07190209

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

Phase III Interventional Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Lunsekimig, Placebo.
Who it may be relevant to: Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Canada, Chile +6
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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