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 3RecruitingNCT07190222

Sanofi942 enrolled

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.

All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

942

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (214)

University of Alabama at Birmingham- Site Number : 8400003

Birmingham, Alabama, United States

RECRUITING

Tucson Clinical Research Institute- Site Number : 8400006

Tucson, Arizona, United States

RECRUITING

Inglewood Clinical- Site Number : 8400074

Inglewood, California, United States

RECRUITING

Ark Clinical Research- Site Number : 8400113

Long Beach, California, United States

Outcomes

Primary Outcomes

Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations

The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo

Time frame: From Baseline up to 48 weeks

Secondary Outcomes

Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)

The post-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Time frame: From Baseline up to 48 weeks

Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)

The pre-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Time frame: From Baseline up to 48 weeks

Change from baseline in the SGRQ-C total score

The St. George's Respiratory Questionnaire for patients with chronic obstructive pulmonary disease is derived from the St. George's Respiratory Questionnaire (SGRQ) and is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.

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

The CAAT is an 8-item patient-reported outcome (PRO) measure designed to assess the impact of chronic airways diseases, including COPD, on patients' health status. The CAAT has a scoring range of 0-40, with higher scores indicating a greater impact of the disease on health status.

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

The Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) is an 11-item patient-reported outcome (PRO) measure that evaluates the severity of respiratory symptoms in patients with stable COPD. The total score ranges from 0 to 40, with higher scores indicating more severe respiratory symptoms.

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 to first occurrence of moderate to severe COPD exacerbation up to 48 weeks

Time frame: From Baseline up to 48 weeks

Time to first severe COPD exacerbation

Time to first occurrence of severe COPD exacerbation up to 48 weeks

Time frame: From Baseline up to 48 weeks

Incidence of participants with TEAEs, including AESIs, and SAEs

Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs)

Time frame: From Baseline up to 56 weeks

Incidence of potentially clinically significant laboratory abnormalities

Time frame: From Baseline up to 56 weeks

Serum concentration of lunsekimig

Time frame: From Baseline up to 48 weeks

Incidence and titer of antidrug antibodies (ADAs)

Time frame: From Baseline up to 48 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (214)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts