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 · NCT06834360
Conditions: Chronic Rhinosinusitis With Nasal Polyps
At a glance
- Research payments reported, 2025
- $667,852
- U.S. investigators named
- 13
- Sites paid
- 13
- Planned or actual enrollment
- 216
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab (SAR440340) (drug), Placebo (drug), Mometasone furoate nasal spray (MFNS) (drug)
- Dates
- Started 2025-02-06; completion 2027-02-17
- Results posted
- Not yet
EFC18419 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 $667,852 in research payments for this study in 2025 (99 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
- John C. Davis, M.D. ENT (Otolaryngology) · Hoover, AL
- Arthur W. Wu, M.D. ENT (Otolaryngology) · Los Angeles, CA
- Jaime Kratz, MD Allergy & Immunology · Port Richey, FL
- Corinna Levine, MD ENT (Otolaryngology) · Miami, FL
- Victoria S. Lee, MD ENT (Otolaryngology) · Chicago, IL
- Keith D. Forwith, MD ENT (Otolaryngology) · Louisville, KY
- Jibran E. Atwi, MD Allergy & Immunology · Lafayette, LA
- Jean Kim, M.D. ENT (Otolaryngology) · Baltimore, MD
- Katie Phillips, M.D. ENT (Otolaryngology) · Cincinnati, OH
- Martha M. Tarpay, MD Allergy & Immunology · Oklahoma City, OK
- Gurston G. Nyquist, M.D. ENT (Otolaryngology) · Philadelphia, PA
- Henry F. Butehorn III, M.D. ENT (Otolaryngology) · Spartanburg, SC
- Marc R. Dean, M.D. ENT (Otolaryngology) · Fort Worth, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- $153,698
- Martha Tarpay MD Allergy Asthma and Clinical Researc Center $107,981
- Elias Research Associates LLC $80,649
- Berkson Medical Llc $42,263
- Johns Hopkins University $40,438
- University of Cincinnati $39,860
- Cedars-Sinai Medical Center, CA $37,912
- Advanced Ent and Allergy $34,636
- Office of Research Administration $28,154
- University of Illinois Hospital and Clinics, IL $23,300
- Medovation Clinical Research Llc $22,600
- Thomas Jefferson University $22,300
- Velocity Clinical Research Inc $17,755
- Advanced Research Institute New Port Richey $16,307
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.