A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps
Completed · Phase 2 · NCT06691113
Conditions: Chronic Rhinosinusitis Without Nasal Polyps
At a glance
- Research payments reported, 2025
- $965,827
- U.S. investigators named
- 10
- Sites paid
- 10
- Planned or actual enrollment
- 66
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab (SAR440340) (drug), Placebo (drug), Mometasone furoate nasal spray (MFNS) (drug)
- Dates
- Started 2024-12-16; completion 2026-08-12
- Results posted
- Not yet
ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 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 in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. Study details include: * The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks. * The intervention duration will be 24 weeks. * The number of visits will be 7 site visits and 8 phone/remote visits.
From ClinicalTrials.gov, last updated 2026-08-25. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $965,827 in research payments for this study in 2025 (91 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
- Weily Soong, M.D. Specialist · Birmingham, AL
- Matthew E. Leach, M.D. ENT (Otolaryngology) · Murrieta, CA
- Brian D. Modena, M.D., MSC Allergy & Immunology · La Jolla, CA
- Randall A. Ow ENT (Otolaryngology) · Loomis, CA
- Jeffrey S. Rumbyrt, M. D. Allergy & Immunology · Lakewood, CO
- Abraham Jaguan, M.D. ENT (Otolaryngology) · Miami, FL
- Neetu Talreja, MD Hospitalist · Detroit, MI
- Chad M. Mcduffie, M.D. ENT (Otolaryngology) · Frisco, TX
- Jeffery S. Rosenbloom, MD ENT (Otolaryngology) · San Antonio, TX
- Joseph K. Han, MD ENT (Otolaryngology) · Norfolk, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Davinci Research LLC $284,388
- Berkson Medical Llc $248,826
- Brian D Modena Orso Health Inc $139,547
- Western States Clinical Research in $75,924
- Treasure Valley Medical Research Neetu Talreja $61,110
- Ara Professionals Llc $55,883
- Clinical Research Center of Alabama LLC $51,497
- Old Dominion University $16,128
- Alamo Ent Associates $13,265
- United Medical Doctors United Gastroenterologists $12,800
- $6,459
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.