A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
Completed · Phase 2 · NCT06454240
Conditions: Chronic Rhinosinusitis With Nasal Polyps
At a glance
- Research payments reported, 2025
- $1.0M
- U.S. investigators named
- 15
- Sites paid
- 16
- Planned or actual enrollment
- 79
About the trial
- Sponsor
- Sanofi
- Tested
- lunsekimig (drug), placebo (drug)
- Dates
- Started 2024-07-17; completion 2026-04-23
- Results posted
- Not yet
This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 we…
From ClinicalTrials.gov, last updated 2026-04-28. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $1.0M in research payments for this study in 2025 (120 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
- 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
- Seong H. Cho, M.D. Allergy & Immunology · Tampa, FL
- Thomas S. Edwards, MD ENT (Otolaryngology) · Decatur, GA
- Neetu Talreja, MD Hospitalist · Detroit, MI
- Scott A. Cordray, DO ENT (Otolaryngology) · Tulsa, OK
- Iftikhar Hussain, MD Allergy & Immunology · Tulsa, OK
- Stella Lee ENT (Otolaryngology) · Pittsburgh, PA
- Gary N. Gross, MD Allergy & Immunology · Dallas, TX
- Amber Luong, M.D., PH.D ENT (Otolaryngology) · Houston, TX
- Chad M. Mcduffie, M.D. ENT (Otolaryngology) · Frisco, TX
- Jeffery S. Rosenbloom, MD ENT (Otolaryngology) · San Antonio, TX
- Nadim B. Bikhazi, MD ENT (Otolaryngology) · Ogden, UT
- 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
- Berkson Medical Llc $144,966
- Treasure Valley Medical Research Neetu Talreja $111,598
- Essential Medical Research LLC $107,695
- Pharmaceutical Research Consulting Inc $84,460
- Tampa VA Research and Education $77,400
- Davinci Research LLC $68,097
- The University of Texas Health Scie Center at Houston $68,012
- Emory University Hospital, GA $64,405
- Brian D Modena Orso Health Inc $63,318
- $60,387
- Old Dominion University $51,103
- Alamo Ent Associates $41,391
- Advanced Research Inc $32,752
- Brigham and Women's Hospital, MA $24,425
- Vital Prospects Clinical Research I Institute PC $10,819
- United Medical Doctors United Gastroenterologists $10,500
- James A Haley Veterans Research Education Found Inc $2,080
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.