A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Completed · Phase 3 · NCT06208306
Conditions: Chronic Obstructive Pulmonary Disease
At a glance
- Research payments reported, 2025
- $5.1M
- U.S. investigators named
- 69
- Sites paid
- 66
- Planned or actual enrollment
- 669
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab (SAR440340) (drug), Placebo (drug)
- Dates
- Started 2024-01-11; completion 2026-09-10
- Results posted
- Not yet
This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: * The study duration will be up to 72 weeks * The treatment duration will be up to 52 wee…
From ClinicalTrials.gov, last updated 2026-09-18. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $5.1M in research payments for this study in 2025 (649 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
- Dena E. Petersen, MD Family Medicine · Tucson, AZ
- Muhammad M. Salim, MD Pulmonology · Chandler, AZ
- Vikas Sayal, M.D. Pulmonology · Bullhead City, AZ
- Andrew P. Morado, M.D. Internal Medicine · Anaheim, CA
- Salil Nadkarni, D.O. Family Medicine · West Hollywood, CA
- David N. Pham, MD Pulmonology · Westminster, CA
- Ricardo A. Tan, MD Allergy & Immunology · Los Angeles, CA
- Thomas M. Wilcox, DO Pulmonology · Boulder, CO
- Leonardo M. Allende, MD Family Medicine · Doral, FL
- Jaime Avecillas, MD Pulmonology · Miami, FL
- Kwabena Ayesu, MD Internal Medicine · Orlando, FL
- Bradley M. Block, MD Family Medicine · Oviedo, FL
- Lourdes T. Bosch, MD Pulmonology · Miami, FL
- Humberto Cruz JR., D.O. Family Medicine · Orlando, FL
- Jorge Diaz Valdes, MD Internal Medicine · Miami, FL
- Jose D. Gomez-cortes, M.D. Internal Medicine · Coral Gables, FL
- Joel Gonzalez, M.D. Internal Medicine · Homestead, FL
- Luis Hernandez Rosado, M.D. Internal Medicine · Pinecrest, FL
- Raj G. Karunakara, M.D. Pulmonology · Ocala, FL
- Carl Landgren, MD Hematology & Oncology · Miami, FL
- Sara N. Llerena, MD OB-GYN (Obstetrics & Gynecology) · Miami, FL
- Lon D. Lynn, D.O. Family Medicine · Tampa, FL
- Alberto Manzor, MD Internal Medicine · Pembroke Pines, FL
- Jaynier Moya, MD Internal Medicine · Pembroke Pines, FL
- Ronoel Penalver, M.D Family Medicine · Pembroke Pines, FL
- Ariel Ramirez Navarro, MD Internal Medicine · Miami, FL
- Alexis R. Renta, M.D. Pain Medicine · Boynton Beach, FL
- Agustin Rivas, M.D. General Practice · Miami Springs, FL
- Franklin D. Saumell, M.D. General Practice · Miami, FL
- Sanjay B. Shah, MD Internal Medicine · The Villages, FL
- Mohammad T. Sheikh General Practice · Lauderhill, FL
- Roberto Sotolongo, MD Internal Medicine · Miami, FL
- Peruvemba S. Sriram, MD Pulmonology · Gainesville, FL
- Manuel Suarez, M.D. Pulmonology · 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
- Patrick E. Whitten, M.D. Pulmonology · Peoria, IL
- Richard E. Casey, M.D. Pulmonology · Covington, LA
- David S. Green, M.D. Specialist · Shreveport, LA
- Paul A. Shapero, MD Allergy & Immunology · Bangor, ME
- Oscar F. Parodi Ortiz De Villate, M.D. Pulmonology · Warren, MI
- Humam W. Farah, M D Critical Care Medicine · Hannibal, MO
- Kaharu Sumino, MD Pulmonology · Saint Louis, MO
- Chandar R. Abboy, M.D. Critical Care Medicine · Fayetteville, NC
- Bryan K. Dunn, MD Pulmonology · Greenville, NC
- Thomas P. Stern, M.D. Pulmonology · Huntersville, NC
- Ahmed Y. Khan, MD Pulmonology · Schenectady, NY
- Karin A. Provost, D.O., PHD Pulmonology · Williamsville, NY
- Syed T. Raza, MD Cardiothoracic Surgery · New York, NY
- Anthony J. Smith, MD Pulmonology · New York, NY
- Robert M. Burkes Pulmonology · Cincinnati, OH
- Jeremy Cole, MD Sleep Medicine · Edmond, OK
- Sandeep Bansal, MD Pulmonology · Du Bois, PA
- Tiffany L. Dumont, D.O. Critical Care Medicine · Pittsburgh, PA
- Michael B. Denenberg, M.D. Pulmonology · Rock Hill, SC
- Carl I. Mitchell, M.D. Internal Medicine · Columbia, SC
- David Fuentes, MD Allergy & Immunology · Boerne, TX
- John M. Joseph, M.D. Rheumatology · Carrollton, TX
- Lisa M. Kopas, M.D. Pulmonology · Houston, TX
- Shahrukh A. Kureishy, MD Pulmonology · Mckinney, TX
- Regina R. Pillai, M.D. Pulmonology · Webster, TX
- Roozbeh Sharif, M.D., M.ED., M.SC. Pulmonology · Nederland, TX
- John D. Updegrove, MD Pulmonology · Corsicana, TX
- Thomas T. Siler JR., MD Internal Medicine · Port Orchard, WA
- Maria R. Boustani, MD Pulmonology · Beckley, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Md Trials Llc Conduct Clinical Trials $440,586
- Dl Research Solutions $315,250
- Care Access Research Llc $288,090
- Pines Care Research Center Llc $281,546
- Reed Medical Research Corp $237,734
- Beautiful Minds Medical Center Llc $213,766
- High Quality Research Inc $173,850
- Advanced Pulmonary Research Institute $152,219
- Cpcc Research LLC $150,826
- My Community Research Center Inc $136,829
- Tucson Clinical Research Institute Llc $135,132
- Allianz Research Institute Co Llc $132,208
- Advanced Pulmonary Research Institute of Michigan PLLC $125,068
- Interspond LLC $120,898
- Kaushlendra Tripathi Medtrial Llc $114,398
- Metroplex Pulmonary and Sleep Center $112,715
- Ricardo Antonio Tan MD Inc $100,649
- Deluxe Health Center $93,345
- Rheumatology and Pulmonary Clinic $91,853
- Ok Clinical Research LLC $88,230
- Alleghenysinger Research Institute $72,030
- Omega Research Debary Llc $71,562
- Paul Shapero, MD $67,788
- Hmd Research Llc $66,192
- Alpha Clinical Research Georgia Llc $58,499
- Oviedo Medical Research $56,709
- Innovation Medical Research Center, Inc $53,566
- Florida Institute for Clinical Research LLC $52,710
- Henderson Clinical Trials Llc $51,007
- Downtown L A Research Center Inc $50,875
- University of Cincinnati $48,955
- Alpine Clinical Research Center Inc $47,378
- Osf Heart of Mary Medical Center, IL $44,546
- Noble Clinical Research $44,113
- Rex Clinical Trials Llc $43,910
- Clinical Research of Rock Hill Clinical Research of the Carolinas $43,035
- Science Connections Llc $42,268
- Renstar Llc Renstar Medical Research $40,871
- Advanced Respiratory and Sleep Medicine, PLLC $40,001
- Vantage Clinical Trials Llc $38,492
- Chandler Clinical Trials Llc $38,303
- The Methodist Hospital Research Institute Houston Methodist Research Institute $37,091
- Elligo Health Research Inc $36,246
- Corsicana Medical Research PLLC $35,009
- Clinical Research Associates of Central PA LLC $34,207
- Clinrx Research Joseph Inc $34,144
- Hannibal Regional Healthcare System Inc $31,843
- Tellabio International Research Services Llc $31,510
- Direct Helpers Medical Center Inc Direct Helpers Research Center $28,800
- Washington University $24,583
- Helix Biomedics Llc $21,611
- Imax Clinical Trials Llc 1 $21,000
- Stern Research PArtners Llc $20,689
- Buffalo Institute for Medical Research Inc $20,517
- Office of Research Administration $20,036
- Revival Research Institute, Inc $19,222
- Newyorkpresbyterian Queens $18,250
- Clinical Research of West Florida $14,933
- Finlay Medical Research Corp $14,739
- Cls Research Center PLLC $13,550
- Appalachian Clinical Research $12,215
- North Florida Found for Research Education $9,500
- East Carolina University Medical Health Sciences Foundation Inc $7,800
- Lsb Research Group Llc Benchmark Research $6,194
- Midwest Chest Consultants, PC $3,450
- Columbus Clinical Services $1,400
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.