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NCT06834360 · 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
NCT06834360 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 14 states.
The verdict
NCT06834360, 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
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Itepekimab (SAR440340)
- DRUG Mometasone furoate nasal spray (MFNS)
Study Locations (20)
California
- Velocity Clinical Research - San Diego- Site Number : 8400041 - La Mesa
- Cedars-Sinai Medical Center- Site Number : 8400030 - Los Angeles
- One of a Kind CLinical Research Center- Site Number : 8400034 - Napa
Florida
- University of Florida - Jacksonville- Site Number : 8400053 - Jacksonville
- University of Miami Don Suffer Clinical Research Building- Site Number : 8400036 - Miami
- Advanced Research Institute - New Port Richey- Site Number : 8400014 - New Port Richey
Other
- Investigational Site Number : 0320002 - Buenos Aires
- Investigational Site Number : 0320001 - Buenos Aires
- Investigational Site Number : 0320004 - Corrientes
Alabama
- Excel ENT of Alabama- Site Number : 8400052 - Birmingham
Illinois
- University of Illinois at Chicago- Site Number : 8400003 - Chicago
Kentucky
- Advanced ENT & Allergy - Louisville- Site Number : 8400007 - Louisville
Louisiana
- Velocity Clinical Research - Lafayette- Site Number : 8400026 - Lafayette
Maryland
- Johns Hopkins Hospital- Site Number : 8400017 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2027-12-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06834360
The ClinicalTrials.gov registry entry for NCT06834360 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.
NCT06834360 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Other.
Frequently Asked Questions
What is clinical trial NCT06834360 about?
NCT06834360 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". 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 corti...
What is the current status of trial NCT06834360?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2025-02-06. Estimated completion is 2027-12-13.
What conditions does trial NCT06834360 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis With Nasal Polyps.
What interventions are being tested in trial NCT06834360?
The interventions under investigation include: Placebo (DRUG), Itepekimab (SAR440340) (DRUG), Mometasone furoate nasal spray (MFNS) (DRUG).
Who is sponsoring clinical trial NCT06834360?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06834360 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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