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 NCT06834347. 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.
EFC18418 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
- NCT06834347
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 231 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 11, 2025
- Primary completion
- Oct 13, 2026
- Completion
- Sep 15, 2027
- Last update posted
- May 19, 2026
2025 – 2027
United States locations
- U.S. sites
- 21
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037 | Arcadia | California | 91006 | — |
| Sensa Health- Site Number : 8400038 | Los Angeles | California | 90006 | — |
| Newport Native MD- Site Number : 8400031 | Newport Beach | California | 92663 | — |
| Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064 | Roseville | California | 95661 | — |
| Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040 | Torrance | California | 90503 | — |
| Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035 | Torrance | California | 90505 | — |
| Advanced Research Associates (ARA) Professionals- Site Number : 8400011 | Miami | Florida | 33176 | — |
| Paradisus Med Research - Miami- Site Number : 8400009 | Miami | Florida | 33185 | — |
| Orlando ENT Associates - Orlando- Site Number : 8400008 | Orlando | Florida | 32807 | — |
| Emory University School of Medicine- Grady Campus- Site Number : 8400047 | Atlanta | Georgia | 30303 | — |
| Treasure Valley Medical Research- Site Number : 8400063 | Boise | Idaho | 83706 | — |
| University of Chicago Medical Center- Site Number : 8400018 | Chicago | Illinois | 60637 | — |
| Deaconess Clinic Allergy East- Site Number : 8400056 | Evansville | Indiana | 47715 | — |
| SSM Health Saint Louis University Hospital- Site Number : 8400005 | St Louis | Missouri | 63104 | — |
| Northwell Health Physician Partners Rheumatology at Great Neck- Site Number : 8400028 | Great Neck | New York | 11021 | — |
| Essential Medical Research- Site Number : 8400066 | Tulsa | Oklahoma | 74137 | — |
| TEN20 Clinical Research - Dallas- Site Number : 8400015 | Dallas | Texas | 75244 | — |
| Houston Methodist Hospital- Site Number : 8400054 | Houston | Texas | 77030 | — |
| ENT Associates of Texas - McKinne- Site Number : 8400062 | McKinney | Texas | 75070 | — |
| Alamo ENT Associates- Site Number : 8400065 | San Antonio | Texas | 78258 | — |
| Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046 | Norfolk | Virginia | 23510 | — |
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 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06834347, 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 May 19, 2026 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06834347 live on ClinicalTrials.gov.