A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Active, not recruiting · Phase 3 · NCT06834347
Conditions: Chronic Rhinosinusitis With Nasal Polyps
At a glance
- Research payments reported, 2025
- $423,082
- U.S. investigators named
- 15
- Sites paid
- 16
- Planned or actual enrollment
- 231
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab (SAR440340) (drug), Placebo (drug), Mometasone furoate nasal spray (MFNS) (drug)
- Dates
- Started 2025-02-12; completion 2027-03-26
- Results posted
- Not yet
EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment durat…
From ClinicalTrials.gov, last updated 2026-10-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $423,082 in research payments for this study in 2025 (75 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
- Kevin J. Choi, M.D. ENT (Otolaryngology) · Los Angeles, CA
- Steven E. Davis, M.D. ENT (Otolaryngology) · Torrance, CA
- Kevin Hur, MD ENT (Otolaryngology) · Arcadia, CA
- Ryan M. Klein, MD Internal Medicine · Newport Beach, CA
- Raffi Tchekmedyian Allergy & Immunology · Torrance, CA
- Cecelia C. Damask, DO ENT (Otolaryngology) · Orlando, FL
- Abraham Jaguan, M.D. ENT (Otolaryngology) · Miami, FL
- Alex J. Marban, M.D. ENT (Otolaryngology) · Hialeah, FL
- Thomas S. Edwards, MD ENT (Otolaryngology) · Decatur, GA
- Christopher M. Low, M.D. ENT (Otolaryngology) · Chicago, IL
- Blanka Kaplan, MD Pediatrics · Great Neck, NY
- Kevin Lunde, M.D. Facial Plastic Surgery · Plano, TX
- Chad M. Mcduffie, M.D. ENT (Otolaryngology) · Frisco, TX
- Jeffery S. Rosenbloom, MD ENT (Otolaryngology) · San Antonio, TX
- Kent K. Lam, M.D. ENT (Otolaryngology) · Norfolk, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Ten20clinical Research $55,119
- Emory University Hospital, GA $48,396
- Paradisus Medical Research Inc $43,237
- Brian D Modena Orso Health Inc $39,570
- The University of Chicago Cardiology $36,400
- The Feinstein Institute for Medical Research $35,008
- Keck Hospital of Usc, CA $21,455
- Ten Twenty Clinical Research $18,640
- Natl Institute of Clinical Research $18,505
- Newportnativemd Inc $17,467
- Old Dominion University $16,128
- Ara Professionals Llc $13,632
- Jkpc Llc $13,040
- Alamo Ent Associates $12,800
- Berkson Medical Llc $12,800
- South Florida Ent Associates $12,800
- $8,085
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.