Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Completed · Phase 3 · NCT04701983
Conditions: Chronic Obstructive Pulmonary Disease
At a glance
- Research payments reported, 2025
- $2.3M
- U.S. investigators named
- 61
- Sites paid
- 59
- Planned or actual enrollment
- 1,127
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab SAR440340 (drug), Placebo (drug)
- Dates
- Started 2020-12-16; completion 2025-08-27
- Results posted
- Yes
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 corti…
From ClinicalTrials.gov, last updated 2026-10-15. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $2.3M in research payments for this study in 2025 (334 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Girish J. Karamchandani, DO Internal Medicine · Tucson, AZ
- Da-wei Liao, MD Pulmonology · Phoenix, AZ
- Muhammad M. Salim, MD Pulmonology · Chandler, AZ
- Vikas Sayal, M.D. Pulmonology · Bullhead City, AZ
- Brian D. Modena, M.D., MSC Allergy & Immunology · La Jolla, CA
- Andrew P. Morado, M.D. Internal Medicine · Anaheim, CA
- Salil Nadkarni, D.O. Family Medicine · West Hollywood, CA
- C A. Schroeder, M.D. Pulmonology · Beverly Hills, CA
- Ricardo A. Tan, MD Allergy & Immunology · Los Angeles, CA
- Thomas M. Wilcox, DO Pulmonology · Boulder, CO
- Warren R. Abel, MD Pulmonology · St Petersburg, FL
- Mohamed I. Ali Eltoum, M.D. Pulmonology · Saint Petersburg, FL
- Jaime Avecillas, MD Pulmonology · Miami, FL
- Peter A. Bercz, M.D. Pulmonology · Pensacola, FL
- Jose F. Cardona, M.D. General Practice · Miami, FL
- Humberto Cruz JR., D.O. Family Medicine · Orlando, FL
- Leonard J. Dunn, MD Pulmonology · Dunedin, FL
- Joel Gonzalez, M.D. Internal Medicine · Homestead, FL
- Ronoel Penalver, M.D Family Medicine · Pembroke Pines, FL
- Ariel Ramirez Navarro, MD Internal Medicine · Miami, FL
- Agustin Rivas, M.D. General Practice · Miami Springs, FL
- Sanjay B. Shah, MD Internal Medicine · The Villages, FL
- Roberto Sotolongo, MD Internal Medicine · Miami, FL
- Manuel Suarez, M.D. Pulmonology · Miami, FL
- Ramses Vega, M.D. Internal Medicine · Miami, FL
- Neal Warshoff, D.O. Pulmonology · Loxahatchee, FL
- David Kavtaradze, M.D. Internal Medicine · Cordele, GA
- Ngozika A. Orjioke, M.D. Pulmonology · East Point, GA
- John J. Trimble III, MD ENT (Otolaryngology) · Acworth, GA
- Marie L. Walton, MD, MPH Research Clinic/Center · Riverdale, GA
- Kenya R. Thomas, MD General Practice · Chicago, IL
- Steven D. Smith, MD Family Medicine · Indianapolis, IN
- Daniel F. Sousa, MD Critical Care Medicine · Fall River, MA
- Chih Chao Yang, MD, MPH, FACP Internal Medicine · Quincy, MA
- Paul A. Shapero, MD Allergy & Immunology · Bangor, ME
- Oscar F. Parodi Ortiz De Villate, M.D. Pulmonology · Warren, MI
- Abdulhassan Saad, M.D. Internal Medicine · Dearborn, MI
- Humam W. Farah, M D Critical Care Medicine · Hannibal, MO
- Thomas M. Siler, MD Pulmonology · Saint Charles, MO
- Chandar R. Abboy, M.D. Critical Care Medicine · Fayetteville, NC
- Bryan K. Dunn, MD Pulmonology · Greenville, NC
- Reginald J. Fowler JR., MD Critical Care Medicine · Winston-salem, NC
- Stephen W. Jones, MD Family Medicine · Shelby, NC
- Mitchell D. Lee, MD Pulmonology · Wilmington, NC
- Bushra Mina, M.D. Pulmonology · New York, NY
- David I. Bernstein, M.D. Allergy & Immunology · Cincinnati, OH
- Steve H. Choi, M.D. Family Medicine · Dayton, OH
- Sandeep Bansal, MD Pulmonology · Du Bois, PA
- Surya P. Bhatt, MD Pulmonology · Bethlehem, PA
- Michael B. Denenberg, M.D. Pulmonology · Rock Hill, SC
- Rajasekaran Annamalai, MD Internal Medicine · Tomball, TX
- Ajay Jain, M.D. Pulmonology · Houston, TX
- John M. Joseph, M.D. Rheumatology · Carrollton, TX
- Mohammad A. Khalil, MD Internal Medicine · Sherman, TX
- Lisa M. Kopas, M.D. Pulmonology · Houston, TX
- Shahrukh A. Kureishy, MD Pulmonology · Mckinney, TX
- Mustafa I. Naeem, M.D. Specialist · Tomball, TX
- Roozbeh Sharif, M.D., M.ED., M.SC. Pulmonology · Nederland, TX
- John D. Updegrove, MD Pulmonology · Corsicana, TX
- Muqdad A. Zuriqat, MD Specialist · Sherman, TX
- Richard W. Casey, MD Radiology · Spokane, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Deluxe Health Center $224,317
- Dl Research Solutions $201,557
- Md Trials Llc Conduct Clinical Trials $192,732
- Advanced Pulmonary Research Institute of Michigan PLLC $133,950
- High Quality Research Inc $109,910
- Tucson Clinical Research Institute Llc $100,904
- Clinrx Research Joseph Inc $91,962
- Reed Medical Research Corp $84,009
- Clinical Research Associates of Central PA LLC $75,681
- Beautiful Minds Medical Center Llc $71,326
- Metroplex Pulmonary and Sleep Center $65,902
- Interspond LLC $64,763
- Brian D Modena Orso Health Inc $57,096
- Midwest Chest Consultants, PC $56,089
- Henderson Clinical Trials Llc $49,842
- Imax Clinical Trials Llc 1 $47,733
- Chandler Clinical Trials Llc $40,979
- Florida Institute for Clinical Research LLC $38,587
- Pensacola Research Consultants Inc Avanza Medical Research Center $34,454
- Biomedical Research Alliance of New York LLC $30,595
- Vantage Clinical Trials Llc $30,212
- Genharp Clinical Solutions $28,500
- Tellabio International Research Services Llc $28,402
- Appalachian Clinical Research $26,176
- Clinical Research of Rock Hill Clinical Research of the Carolinas $26,125
- Ricardo Antonio Tan MD Inc $26,021
- Sonar Clinical Research Llc $24,336
- Corsicana Medical Research PLLC $22,494
- Downtown L A Research Center Inc $22,469
- Care Access Research Llc $21,515
- Hannibal Regional Healthcare System Inc $20,019
- Revival Research Institute, Inc $19,937
- Paul Shapero, MD $17,226
- East Carolina University $16,429
- Rex Tha Clinical Trials Llc $15,982
- Alpha Clinical Research Georgia Llc $14,402
- Dynamed Clinical Research LP $14,018
- Pasadena Center for Medical Research Llc $13,150
- Lsb Research Group Llc Benchmark Research $12,349
- Coastal Medical Research Institute Llc $11,838
- Macro Trials Inc $11,570
- Pulmonary Associates PA $11,350
- The Methodist Hospital Research Institute Houston Methodist Research Institute $10,975
- Elias Research Associates LLC $10,750
- Alpine Clinical Research Center Inc $8,928
- Urgent Care Specialists Llc $7,300
- Hometown Urgent Care of Michigan PC Wellnow Urgent Care Research $7,075
- Sherman Clinical Research $6,300
- Pmg Research Inc $4,650
- Bernstein Clinical Research Center Llc $3,800
- Clinical Research of West Florida $3,500
- University of Alabama Hospital, AL $3,140
- Advanced Pulmonary Research Institute $2,500
- Indago Research Health Center $2,350
- Reliant Medical Research Llc $2,300
- Biopharma Informatic Inc Research Cosultants $1,950
- Mercury Clinical Research Inc $500
- Southeastern Research Center LLC $250
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.