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
Public ClinicalTrials.gov record NCT06834360. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Study identification
- NCT ID
- NCT06834360
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Interventions
- Itepekimab (SAR440340) Drug
- Mometasone furoate nasal spray (MFNS) Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 5, 2025
- Primary completion
- Jan 7, 2027
- Completion
- Dec 12, 2027
- Last update posted
- Apr 23, 2026
2025 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Excel ENT of Alabama- Site Number : 8400052 | Birmingham | Alabama | 35244 | Recruiting |
| Velocity Clinical Research - San Diego- Site Number : 8400041 | La Mesa | California | 91942 | Recruiting |
| Cedars-Sinai Medical Center- Site Number : 8400030 | Los Angeles | California | 90048 | Recruiting |
| One of a Kind CLinical Research Center- Site Number : 8400034 | Napa | California | 94558 | Recruiting |
| University of Florida - Jacksonville- Site Number : 8400053 | Jacksonville | Florida | 32209 | Recruiting |
| University of Miami Don Suffer Clinical Research Building- Site Number : 8400036 | Miami | Florida | 33136 | Recruiting |
| Advanced Research Institute - New Port Richey- Site Number : 8400014 | New Port Richey | Florida | 34653 | Recruiting |
| University of Illinois at Chicago- Site Number : 8400003 | Chicago | Illinois | 60607 | Recruiting |
| Advanced ENT & Allergy - Louisville- Site Number : 8400007 | Louisville | Kentucky | 40220 | Recruiting |
| Velocity Clinical Research - Lafayette- Site Number : 8400026 | Lafayette | Louisiana | 70508 | Recruiting |
| Johns Hopkins Hospital- Site Number : 8400017 | Baltimore | Maryland | 21287 | Recruiting |
| University of Cincinnati Medical Center- Site Number : 8400022 | Cincinnati | Ohio | 45219 | Recruiting |
| Allergy, Asthma and Clinical Research- Site Number : 8400002 | Oklahoma City | Oklahoma | 73120 | Recruiting |
| Thomas Jefferson University Hospital- Site Number : 8400044 | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Spartanburg-Greer ENT & Allergy- Site Number : 8400039 | Greer | South Carolina | 29650 | Recruiting |
| Ear and Sinus Institute- Site Number : 8400048 | Fort Worth | Texas | 76104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 97 non-U.S. sites.
Recently updated Chronic Rhinosinusitis With Nasal Polyps trials
Other public records listing Chronic Rhinosinusitis With Nasal Polyps. Sorted by last update posted; newest first. Not a recommendation.
- NCT07424144: An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps Active, not recruiting
- NCT06914908: Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study Recruiting
- NCT06834347: 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 Recruiting
- NCT06706817: A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab Recruiting
- NCT05246267: Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis Recruiting
- NCT06118554: 3D Printing to Improve Nasal Irrigation Outcome Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06834360, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2026 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06834360 live on ClinicalTrials.gov.