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COMPLETED

NCT04751487

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: Primary population (former smokers cohort): * 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: Primary population (former smokers cohort): * 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 Secondary population (current smokers cohort) * Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD * Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD * Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD * Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD * Estimate immunogenicity to itepekimab in current 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

1239

Start Date

2021-02-12

Completion Date

2025-08-28

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: * For former smokers: participants who report that they are not currently smoking and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently. * For current smokers: participants who report that they are currently smoking tobacco (participant smoked at least 1 cigarette per day on average during the past 7 days) at Screening (Visit 1A) and who are not currently participating in or planning to initiate a smoking cessation intervention at Screening (Visit 1A) or during Screening period. * 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. * For former smokers: Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol \[THC\]) within 6 months prior to Screening (Visit 1A). * For current smokers: vaping of any products (eg, nicotine, 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 Screening (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 (297)

Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333

Phoenix, Arizona, United States

UCSF Fresno - Site Number : 8400030

Fresno, California, United States

Palmtree Clinical Research Site Number : 8400184

Palm Springs, California, United States

Allianz Research Institute Colorado Site Number : 8400061

Denver, Colorado, United States

Helix Biomedics, LLC - Site Number : 8400049

Boynton Beach, Florida, United States

Innovative Research of West Florida, Inc- Site Number : 8400041

Clearwater, Florida, United States

Beautiful Minds Clinical Research Center Site Number : 8400352

Cutler Bay, Florida, United States

Omega Research - Site Number : 8400031

DeBary, Florida, United States

Sciences Connections, LLC Site Number : 8400045

Doral, Florida, United States

North Florida/South Georgia Veterans Health System Site Number : 8400176

Gainesville, Florida, United States

Finlay Medical Research- Site Number : 8400011

Greenacres City, Florida, United States

Direct Helpers Medical Center Inc- Site Number : 8400065

Hialeah, Florida, United States

Multi-Specialty Research Associates, Inc- Site Number : 8400044

Lake City, Florida, United States

Advanced Pulmonary Research Institute Site Number : 8400018

Loxahatchee Groves, Florida, United States

Columbus Clinical Services- Site Number : 8400054

Miami, Florida, United States

Finlay Medical Research Site Number : 8400007

Miami, Florida, United States

MCR Research Site Number : 8400425

Miami, Florida, United States

Y and L Advance Health Care, Inc D/B/A Elite Clinical Res- Site Number : 8400009

Miami, Florida, United States

My Community Research Center Site Number : 8400060

Miami, Florida, United States

Phoenix Medical Research- Site Number : 8400019

Miami, Florida, United States

Renstar Medical Research- Site Number : 8400015

Ocala, Florida, United States

Central Florida Pulmonary Group, PA- Site Number : 8400192

Orlando, Florida, United States

Heuer M.D. Research Site Number : 8400016

Orlando, Florida, United States

Oviedo Medical Research Site Number : 8400026

Oviedo, Florida, United States

Innovation Medical Research Center- Site Number : 8400067

Palmetto Bay, Florida, United States

Pines Care Research Center LLC- Site Number : 8400056

Pembroke Pines, Florida, United States

Sarasota Memorial Health Care System Clinical ResearchCenter- Site Number : 8400178

Sarasota, Florida, United States

Genesis Clinical Research, LLC Site Number : 8400182

Tampa, Florida, United States

Clinical Research of West Florida, Inc- Site Number : 8400008

Tampa, Florida, United States

Medster Research, LLC Site Number : 8400051

Valdosta, Georgia, United States

North Georgia Clinical Research Site Number : 8400013

Woodstock, Georgia, United States

Care Access Fairview Heights Site Number : 8400033

Fairview Heights, Illinois, United States

Captain James A. Lovell Federal Health Care Center Site Number : 8400032

North Chicago, Illinois, United States

Illinois Lung Institute- Site Number : 8400024

Peoria, Illinois, United States

The Iowa Clinic Site Number : 8400034

West Des Moines, Iowa, United States

Cotton O'Neil Garfield- Site Number : 8400063

Topeka, Kansas, United States

Lexington VA Health Care System- Site Number : 8400036

Lexington, Kentucky, United States

Pulmonary & Critical Care Site Number : 8400047

Shreveport, Louisiana, United States

Johns Hopkins Asthma and Allergy Center- Site Number : 8400055

Baltimore, Maryland, United States

Care Access Site Number : 8400276

Boston, Massachusetts, United States

Care Access Site Number : 8400281

Boston, Massachusetts, United States

Henry Ford Hospital Site Number : 8400052

Detroit, Michigan, United States

Revive Research Institute Site Number : 8400186

Lathrup Village, Michigan, United States

Washington University School of Medicine- Site Number : 8400035

St Louis, Missouri, United States

Sierra Clinical Research- Site Number : 8400005

Las Vegas, Nevada, United States

Smart Medical Research Site Number : 8400191

Brooklyn, New York, United States

VA Western New York Healthcare System Site Number : 8400050

Buffalo, New York, United States

New York - Presbyterian Queens- Site Number : 8400028

Flushing, New York, United States

Schenectady Pulmonary and Critical Care Associates- Site Number : 8400029

Schenectady, New York, United States

American Health Research- Site Number : 8400002

Charlotte, North Carolina, United States

Advanced Respiratory and Sleep Medicine- Site Number : 8400022

Huntersville, North Carolina, United States

University of Cincinnati- Site Number : 8400042

Cincinnati, Ohio, United States

Remington-Davis Inc- Site Number : 8400004

Columbus, Ohio, United States

Toledo Institute of Clinical Research- Site Number : 8400014

Toledo, Ohio, United States

OK Clinical Research LLC- Site Number : 8400001

Edmond, Oklahoma, United States

Kaiser Permanente Center for Health Research Site Number : 8400039

Portland, Oregon, United States

St. Luke's University Health Network- Site Number : 8400187

Bethlehem, Pennsylvania, United States

Temple University Hospital Site Number : 8400062

Philadelphia, Pennsylvania, United States

Allegheny Health Network- Site Number : 8400058

Pittsburgh, Pennsylvania, United States

Lowcountry Lung & Critical Care- Site Number : 8400175

Charleston, South Carolina, United States

Medtrial, LLC Site Number : 8400048

Columbia, South Carolina, United States

VitaLink Research- Gaffney- Site Number : 8400003

Gaffney, South Carolina, United States

Clinical Trials Center of Middle Tennessee Site Number : 8400025

Franklin, Tennessee, United States

TTS Research- Site Number : 8400012

Boerne, Texas, United States

United Memorial Medical Center (UMMC)- Site Number : 8400193

Houston, Texas, United States

Radiance Clinical Research- Site Number : 8400037

Lampasas, Texas, United States

Clincove: Plano Primary Care Clinic Site Number : 8400424

Plano, Texas, United States

Sun Research Institute - Site Number : 8400183

San Antonio, Texas, United States

AES Salt Lake City- Site Number : 8400332

Murray, Utah, United States

The Rheumatology and Pulmonary Clinic- Site Number : 8400053

Beckley, West Virginia, United States

Aurora BayCare Medical Center Site Number : 8400046

Green Bay, Wisconsin, United States

Investigational Site Number : 0320009

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320008

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320005

Pergamino, Buenos Aires, Argentina

Investigational Site Number : 0320006

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320002

Vicente Lopez, Buenos Aires F.D., Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320003

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320004

Rosario, Santa Fe Province, Argentina

CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES- Site Number : 0760009

Vitória, Espírito Santo, Brazil

SER da Bahia- Site Number : 0760020

Salvador, Estado de Bahia, Brazil

CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza- Site Number : 0760018

Brasília, Federal District, Brazil

Hospital Sao Domingos- Site Number : 0760016

São Luís, Maranhão, Brazil

Santa Casa de Belo Horizonte - Hospital Emygdio Germano- Site Number : 0760014

Belo Horizonte, Minas Gerais, Brazil

CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760012

Curitiba, Paraná, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Ceos Site Number : 0760021

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas da PUCRS- Site Number : 0760007

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao- Site Number : 0760006

Porto Alegre, Rio Grande do Sul, Brazil

Faculdade de Medicina da Universidade Estadual Paulista- Site Number : 0760005

Botucatu, São Paulo, Brazil

PUC Campinas - Sociedade Campineira de Educaçao e Instruçao- Site Number : 0760010

Campinas, São Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clinicos- Site Number : 0760015

São Bernardo do Campo, São Paulo, Brazil

Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo- Site Number : 0760013

São Paulo, São Paulo, Brazil

Clinica de Alergia Martti Antila Site Number : 0760008

Sorocaba, São Paulo, Brazil

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017

Rio de Janeiro, Brazil

CEPIC - Centro Paulista de Investigação Clínica- Site Number : 0760004

São Paulo, Brazil

Investigational Site Number : 1000008

Blagoevgrad, Bulgaria

Investigational Site Number : 1000013

Dupnitsa, Bulgaria

Investigational Site Number : 1000004

Gabrovo, Bulgaria

Investigational Site Number : 1000009

Haskovo, Bulgaria

Investigational Site Number : 1000005

Montana, Bulgaria

Investigational Site Number : 1000002

Plovdiv, Bulgaria

Investigational Site Number : 1000012

Rousse, Bulgaria

Investigational Site Number : 1000003

Rousse, Bulgaria

Investigational Site Number : 1000001

Sofia, Bulgaria

Investigational Site Number : 1000006

Sofia, Bulgaria

Investigational Site Number : 1240006

Sherwood Park, Alberta, Canada

Investigational Site Number : 1240014

Kelowna, British Columbia, Canada

Investigational Site Number : 1240016

Penticton, British Columbia, Canada

Investigational Site Number : 1240012

Moncton, New Brunswick, Canada

Investigational Site Number : 1240021

Ajax, Ontario, Canada

Investigational Site Number : 1240020

Burlington, Ontario, Canada

Investigational Site Number : 1240023

Guelph, Ontario, Canada

Investigational Site Number : 1240009

Toronto, Ontario, Canada

Investigational Site Number : 1240022

Windsor, Ontario, Canada

Investigational Site Number : 1240018

Windsor, Ontario, Canada

Investigational Site Number : 1240004

Sherbrooke, Quebec, Canada

Investigational Site Number : 1240005

St-charles Borrommee, Quebec, Canada

Investigational Site Number : 1240019

Terrebonne, Quebec, Canada

Investigational Site Number : 1240001

Trois-Rivières, Quebec, Canada

Investigational Site Number : 1240002

Victoriaville, Quebec, Canada

Investigational Site Number : 1240003

Québec, Canada

Investigational Site Number : 1520009

Valdivia, Los Ríos Region, Chile

Investigational Site Number : 1520002

Talca, Maule Region, Chile

Investigational Site Number : 1520007