Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

Investigation of an investigational medication for COPD in former smokers

Not Recruiting
40 years - 85 years
All
Phase 3
930 participants needed

Study Overview

Primary Objective:
Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives:
  • Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
  • Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
  • Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
  • Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Study Details

The study duration per participant is approximatively 76 weeks including a 3-to-5-week screening period, a 52-week treatment period on investigational medicinal product (IMP) and a 20-week post-IMP treatment follow-up period.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Obstructive Pulmonary Disease
  • Age: 40 years - 85 years
  • Gender: All

Inclusion criteria :
  • Participant must be 40 to 85 years of age inclusive.
  • Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition.
  • Smoking history of ≥10 pack-years, but who are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
  • Participants with moderate-to-severe COPD
  • Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been excluded).
  • Documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy:
    • Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
    • Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility.
  • Participants with standard of care controller therapy, for ≥3 months prior to
    Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.
  • Body mass index (BMI) ≥18.0 kg/m^2
  • Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    • not a women of child-bearing potential (WOCBP) OR
    • a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.
Exclusion criteria:
  • Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.
  • Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A).
  • Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participant's participation in the study.
  • Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
  • Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.
  • Hypercapnia requiring bilevel positive airway pressure (BiPAP).
  • Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A).
  • Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.
  • Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A).
  • Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.
  • Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of anti-hypertensive therapy).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
  • History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A).
  • Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to sScreening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
  • Evidence of acute or chronic infection requiring systemic treatment with anti bacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment).
  • Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis.
  • History of malignancy within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
  • Previous use of itepekimab.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Updated on 12 Jun 2025. Study ID: NCT04701983

This study investigates the effects of an investigational medication compared to a placebo on chronic obstructive pulmonary disease (COPD) in former smokers. COPD is a lung condition that makes it hard to breathe. The study focuses on people who have moderate to severe COPD and have quit smoking. Researchers want to see if the investigational medication can reduce the number of times these patients have serious flare-ups of their COPD symptoms.

Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will measure lung function, symptoms, and overall health quality. Participants will also be monitored for any side effects and changes in their condition.

  • Who can participate: Adults aged 40 to 85 who have been diagnosed with moderate to severe COPD for at least a year and have quit smoking at least 6 months ago can participate. They must have a history of significant COPD exacerbations, a BMI of ≥18.0 kg/m², and be on a stable dose of controller therapy for at least 1 month prior to screening. Participants must not have asthma or other significant lung diseases.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. They will continue their usual COPD treatments and visit the study site for regular health checks. Participants should not have had a moderate or severe exacerbation within 4 weeks prior to screening. The study will track lung function, symptoms, and any side effects.
  • Study timelines: The study will last 76 weeks.