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NCT06691113 · ClinicalTrials.gov registry record · Phase 2
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps
A Phase 2 study of Chronic Rhinosinusitis Without Nasal Polyps, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT06691113: Active Phase 2 study of Chronic Rhinosinusitis Without Nasal Polyps, sponsored by Sanofi.
NCT06691113 is a Phase 2 study of Chronic Rhinosinusitis Without Nasal Polyps that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06691113, a Phase 2 study of Chronic Rhinosinusitis Without Nasal Polyps, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 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 in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. Study details include: * The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks. * The intervention duration will be 24 weeks. * The number of visits will be 7 site visits and 8 phone/remote visits.
Primary Outcome
Change from baseline in sinus inflammation as assessed by Computerized Tomography (CT) scan of the sinuses in the itepekimab-- compared to placebo-- treated study participants on the background of intranasal corticosteroid (INCS).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Itepekimab (SAR440340)
- DRUG Mometasone furoate nasal spray (MFNS)
Study Locations (20)
Other
- Investigational Site Number : 0320001 - Buenos Aires
- Investigational Site Number : 0320004 - Corrientes
- Investigational Site Number : 0560003 - Brussels
- Investigational Site Number : 0560004 - Gesves
- Investigational Site Number : 0560002 - Ghent
- Investigational Site Number : 0560001 - Leuven
California
- Modena Allergy + Asthma- Site Number : 8400005 - La Jolla
- United Medical Doctors - Murrieta- Site Number : 8400001 - Murrieta
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008 - Roseville
Texas
- ENT Associates of Texas - McKinne- Site Number : 8400013 - McKinney
- Alamo ENT Associates- Site Number : 8400026 - San Antonio
Quebec
- Investigational Site Number : 1240002 - Montreal
- Investigational Site Number : 1240001 - Québec
Alabama
- Allervie Clinical Research - Birmingham- Site Number : 8400006 - Birmingham
Colorado
- Western States Clinical Research- Site Number : 8400009 - Wheat Ridge
Florida
- Advanced Research Associates (ARA) Professionals- Site Number : 8400002 - Miami
Idaho
- Treasure Valley Medical Research- Site Number : 8400022 - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2027-02-09 |
| Phase | Phase 2 |
What the registry record for NCT06691113 still lists
NCT06691113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Chronic Rhinosinusitis Without Nasal Polyps appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06691113 names 20 study sites across 11 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06691113 about?
NCT06691113 is a clinical study titled "A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps". ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 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 in male and female participants with ...
What is the current status of trial NCT06691113?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-12-16. Estimated completion is 2027-02-09.
What conditions does trial NCT06691113 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis Without Nasal Polyps.
What interventions are being tested in trial NCT06691113?
The interventions under investigation include: Placebo (DRUG), Itepekimab (SAR440340) (DRUG), Mometasone furoate nasal spray (MFNS) (DRUG).
Who is sponsoring clinical trial NCT06691113?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06691113 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06691113's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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