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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
NCT06834360 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06834360 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06834360?
The interventions under investigation include: Placebo (DRUG), Itepekimab (SAR440340) (DRUG), Mometasone furoate nasal spray (MFNS) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06834360?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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