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NCT06834347 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Chronic Rhinosinusitis With Nasal Polyps, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT06834347 is a Phase 3 study of Chronic Rhinosinusitis With Nasal Polyps that is actively recruiting participants, run by Sanofi. The registered enrollment target is 210 participants, above the 123-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT06834347, a Phase 3 study of Chronic Rhinosinusitis With Nasal Polyps, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Itepekimab (SAR440340)
- DRUG Mometasone furoate nasal spray (MFNS)
Study Locations (20)
California
- University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037 - Arcadia
- Sensa Health- Site Number : 8400038 - Los Angeles
- Newport Native MD- Site Number : 8400031 - Newport Beach
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064 - Roseville
- Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040 - Torrance
- Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035 - Torrance
Texas
- TEN20 Clinical Research - Dallas- Site Number : 8400015 - Dallas
- Houston Methodist Hospital- Site Number : 8400054 - Houston
- ENT Associates of Texas - McKinne- Site Number : 8400062 - McKinney
- Alamo ENT Associates- Site Number : 8400065 - San Antonio
Florida
- Advanced Research Associates (ARA) Professionals- Site Number : 8400011 - Miami
- Paradisus Med Research - Miami- Site Number : 8400009 - Miami
- Orlando ENT Associates - Orlando- Site Number : 8400008 - Orlando
Georgia
- Emory University School of Medicine- Grady Campus- Site Number : 8400047 - Atlanta
Idaho
- Treasure Valley Medical Research- Site Number : 8400063 - Boise
Illinois
- University of Chicago Medical Center- Site Number : 8400018 - Chicago
Indiana
- Deaconess Clinic Allergy East- Site Number : 8400056 - Evansville
Missouri
- SSM Health Saint Louis University Hospital- Site Number : 8400005 - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2025-02-12 |
| Est. Completion | 2027-12-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06834347
The ClinicalTrials.gov registry entry for NCT06834347 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 123-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (71% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Rhinosinusitis With Nasal Polyps appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06834347 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT06834347 about?
NCT06834347 is a clinical study titled "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". 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 corti...
What is the current status of trial NCT06834347?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2025-02-12. Estimated completion is 2027-12-13.
What conditions does trial NCT06834347 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis With Nasal Polyps.
What interventions are being tested in trial NCT06834347?
The interventions under investigation include: Placebo (DRUG), Itepekimab (SAR440340) (DRUG), Mometasone furoate nasal spray (MFNS) (DRUG).
Who is sponsoring clinical trial NCT06834347?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06834347 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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