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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.
Study identification
- NCT ID
- NCT06834360
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 216 participants
Conditions and interventions
Conditions
Interventions
- Itepekimab (SAR440340) Drug
- Placebo Drug
- Mometasone furoate nasal spray (MFNS) 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 6, 2025 (Actual)
- Primary completion
- Sep 24, 2026 (Actual)
- Completion
- Feb 17, 2027 (Estimated)
- Last update posted
- Oct 21, 2026
2025 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Excel ENT of Alabama- Site Number : 8400052 | Birmingham | Alabama | 35244 | — |
| Velocity Clinical Research - San Diego- Site Number : 8400041 | La Mesa | California | 91942 | — |
| Cedars-Sinai Medical Center- Site Number : 8400030 | Los Angeles | California | 90048 | — |
| One Of A Kind Clinical Research Center- Site Number : 8400034 | Napa | California | 94558 | — |
| University of Florida - Jacksonville- Site Number : 8400053 | Jacksonville | Florida | 32209 | — |
| Advanced Research Institute - New Port Richey- Site Number : 8400014 | New Port Richey | Florida | 34653 | — |
| University of Illinois at Chicago- Site Number : 8400003 | Chicago | Illinois | 60607 | — |
| Advanced ENT & Allergy - Louisville- Site Number : 8400007 | Louisville | Kentucky | 40220 | — |
| Velocity Clinical Research - Lafayette- Site Number : 8400026 | Lafayette | Louisiana | 70508 | — |
| Johns Hopkins Hospital- Site Number : 8400017 | Baltimore | Maryland | 21287 | — |
| University of Cincinnati Medical Center- Site Number : 8400022 | Cincinnati | Ohio | 45219 | — |
| Allergy, Asthma and Clinical Research- Site Number : 8400002 | Oklahoma City | Oklahoma | 73120 | — |
| Thomas Jefferson University Hospital- Site Number : 8400044 | Philadelphia | Pennsylvania | 19107 | — |
| Spartanburg-Greer ENT & Allergy- Site Number : 8400039 | Greer | South Carolina | 29650 | — |
| Ear and Sinus Institute- Site Number : 8400048 | Fort Worth | Texas | 76104 | — |
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 96 non-U.S. sites.
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 Oct 21, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06834360 live on ClinicalTrials.gov.