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NCT04701983

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

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

Official title: Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1127

Start Date

2020-12-16

Completion Date

2025-08-27

Last Updated

2026-04-15

Healthy Volunteers

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

DRUG

Itepekimab SAR440340

Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

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, or BMI ≥16.0 kg/m\^2 for participants enrolled in East-Asian countries. * 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 unless asthma resolved before 18 years of age and has not recurred. * 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 antibacterial, 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.

Locations (248)

University of Alabama at Birmingham Site Number : 8400012

Birmingham, Alabama, United States

Jasper Summit Research Site Number : 8400178

Jasper, Alabama, United States

Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034

Chandler, Arizona, United States

Pulmonary Associates Site Number : 8400392

Phoenix, Arizona, United States

Noble Clinical Research Site Number : 8400182

Tucson, Arizona, United States

Tucson Clinical Research Institute Site Number : 8400431

Tucson, Arizona, United States

California Research Institute Site Number : 8400400

Huntington Park, California, United States

Modena Allergy + Asthma Site Number : 8400036

La Jolla, California, United States

Imax Clinical Trials LLC 1 Site Number : 8400419

La Palma, California, United States

Downtown LA Research Center Inc. Site Number : 8400027

Los Angeles, California, United States

MACRO Trials Site Number : 8400030

Los Angeles, California, United States

Antelope Valley Clinical Trials Site Number : 8400003

Northridge, California, United States

~Alpine Clinical Research Center Site Number : 8400180

Boulder, Colorado, United States

Innovative Clinical Research Site Number : 8400017

Lafayette, Colorado, United States

Clin Research W Florida Site Number : 8400004

Clearwater, Florida, United States

Beautiful Minds Clinical Research Center Site Number : 8400037

Cutler Bay, Florida, United States

Indago Research and Health Center Site Number : 8400187

Hialeah, Florida, United States

Advanced Clinical Research Site Number : 8400409

Kendall, Florida, United States

Advanced Pulmonary Research Institute Site Number : 8400455

Loxahatchee Groves, Florida, United States

University of Miami/Miami VA Medical Center Site Number : 8400026

Miami, Florida, United States

DL Research Solutions Inc Site Number : 8400033

Miami, Florida, United States

My Community Research Center Site Number : 8400347

Miami, Florida, United States

Reliant Medical Research Site Number : 8400397

Miami, Florida, United States

Research Institute of South Florida,Inc Site Number : 8400006

Miami, Florida, United States

PROLIVE MEDICAL RESEARCH Site Number : 8400420

Miami, Florida, United States

Reed Medical Research Site Number : 8400032

Miami, Florida, United States

High Quality Research Site Number : 8400406

Miami, Florida, United States

Deluxe Health Center Site Number : 8400188

Miami Lakes, Florida, United States

Florida Institute for Clinical Research Site Number : 8400013

Orlando, Florida, United States

Tellabio International Research Services Site Number : 8400411

Pembroke Pines, Florida, United States

Avanza Medical Research Center Site Number : 8400376

Pensacola, Florida, United States

Broward Pulmonary and Sleep Specialists Site Number : 8400031

Plantation, Florida, United States

Coastal Medical Research Institute Site Number : 8400044

St. Petersburg, Florida, United States

Pasadena Center for Medical Research Site Number : 8400043

St. Petersburg, Florida, United States

AdtreMed Site Number : 8400442

Tampa, Florida, United States

Premier Medical Associates Site Number : 8400388

The Villages, Florida, United States

Appalachian Clinical Research Site Number : 8400024

Adairsville, Georgia, United States

Covenant Pulmonary Critical Care Site Number : 8400183

Atlanta, Georgia, United States

David Kavtaradze MD, Inc. Site Number : 8400029

Cordele, Georgia, United States

Alpha Clinical Research Georgia Site Number : 8400190

Dunwoody, Georgia, United States

Gwinnett Biomedical Research Site Number : 8400007

Lawrenceville, Georgia, United States

GenHarp Clinical Solutions Site Number : 8400028

Evergreen Park, Illinois, United States

ASHA Clinical Research Site Number : 8400408

Hammond, Indiana, United States

Benchmark Research Site Number : 8400193

Covington, Louisiana, United States

Paul Shapero, PC Site Number : 8400016

Bangor, Maine, United States

Care Access Site Number : 8400276

Boston, Massachusetts, United States

Care Access Site Number : 8400277

Boston, Massachusetts, United States

Care Access Site Number : 8400278

Boston, Massachusetts, United States

Care Access Site Number : 8400280

Boston, Massachusetts, United States

Care Access Site Number : 8400281

Boston, Massachusetts, United States

Exordia Medical Research, Inc. Site Number : 8400041

Fall River, Massachusetts, United States

Revival Research Institute, LLC Site Number : 8400191

Dearborn, Michigan, United States

Advanced Pulmonary Research Institute of Michigan Site Number : 8400403

Warren, Michigan, United States

Hannibal Clinic Site Number : 8400383

Hannibal, Missouri, United States

Midwest Chest Consultants, P.C. Site Number : 8400002

Saint Charles, Missouri, United States

Hendeson Clinical Trials Site Number : 8400365

Henderson, Nevada, United States

Northwell Health Site Number : 8400019

Mount Kisco, New York, United States

WellNow Urgent Care and Clinical Research Site Number : 8400378

Schenectady, New York, United States

Gastonia Pharmaceutical Research Site Number : 8400010

Gastonia, North Carolina, United States

East Carolina University Brody School Of Medicine Site Number : 8400022

Greenville, North Carolina, United States

Carolina Research Center Site Number : 8400005

Shelby, North Carolina, United States

Accellacare Site Number : 8400001

Wilmington, North Carolina, United States

Southeastern Research Center Site Number : 8400011

Winston-Salem, North Carolina, United States

Bernstein Clinical Research Center Site Number : 8400014

Cincinnati, Ohio, United States

WellNow Urgent Care and Research Site Number : 8400039

Springdale, Ohio, United States

Clinical Research of Central PA Site Number : 8400023

DuBois, Pennsylvania, United States

Bogan Sleep Consultants Site Number : 8400181

Columbia, South Carolina, United States

Clinical Research of Rock Hill Site Number : 8400008

Rock Hill, South Carolina, United States

REX Clinical Trials Site Number : 8400371

Beaumont, Texas, United States

Clinrx Research Site Number : 8400021

Carrollton, Texas, United States

Austin Pulmonary Consultants Site Number : 8400035

Cedar Park, Texas, United States

Corsicana Medical Research, LLC Site Number : 8400018

Corsicana, Texas, United States

Premier Pulmonary Critical Care and Sleep Medicine Site Number : 8400440

Denison, Texas, United States

Texas Tech University Health Sciences Center Site Number : 8400189

El Paso, Texas, United States

The Methodist Hospital Research Institute Site Number : 8400194

Houston, Texas, United States

Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038

Houston, Texas, United States

Santa Clara Family Clinic Site Number : 8400398

Houston, Texas, United States

Metroplex Pulmonary and Sleep Center Site Number : 8400015

McKinney, Texas, United States

PRX Research Site Number : 8400380

Mesquite, Texas, United States

The Lung and Sleep Research Institute of North Texas Site Number : 8400417

North Richland Hills, Texas, United States

Clincove: Plano Primary Care Clinic Site Number : 8400424

Plano, Texas, United States

EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414

Plano, Texas, United States

Advance Lung and Sleep Center Site Number : 8400040

Sherman, Texas, United States

Sherman Clinical Research Site Number : 8400009

Sherman, Texas, United States

DM Clinical Research Site Number : 8400179

Tomball, Texas, United States

Clearlake Specialties Site Number : 8400025

Webster, Texas, United States

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320005

La Plata, Buenos Aires, Argentina

Investigational Site Number : 0320003

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320004

Mendoza, Argentina

Investigational Site Number : 1000005

Dimitrovgrad, Bulgaria

Investigational Site Number : 1000001

Sofia, Bulgaria

Investigational Site Number : 1000004

Sofia, Bulgaria

Investigational Site Number : 1000002

Sofia, Bulgaria

Investigational Site Number : 1000009

Sofia, Bulgaria

Investigational Site Number : 1000006

Stara Zagora, Bulgaria

Investigational Site Number : 1000003

Stara Zagora, Bulgaria

Investigational Site Number : 1000007

Veliko Tyrnovo, Bulgaria

Investigational Site Number : 1000008

Vidin, Bulgaria

Investigational Site Number : 1520008

Temuco, La Araucanía, Chile

Investigational Site Number : 1520007

Curicó, Maule Region, Chile

Investigational Site Number : 1520002

Talca, Maule Region, Chile

Investigational Site Number : 1520009