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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: Recruiting Phase 3 study of Chronic Rhinosinusitis With Nasal Polyps, sponsored by Sanofi.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).

Conditions Studied

Chronic Rhinosinusitis With Nasal Polyps

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

FieldValue
Enrollment Target 210 participants
Start Date 2025-02-12
Est. Completion 2027-12-13
Phase Phase 3
Sanofi

713 total trials

What NCT06834347 shows while recruiting

NCT06834347 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (71% higher).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Chronic Rhinosinusitis With Nasal Polyps

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06834347's enrollment target sits among peer trials

210 2nd of 11 higher than 9 of 11 other Chronic Rhinosinusitis With Nasal Polyps trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Rhinosinusitis With Nasal Polyps trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06834347

Source: ClinicalTrials.gov NCT06834347, the US trial registry maintained by the National Library of Medicine. NCT06834347 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.