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NCT06454240 · ClinicalTrials.gov registry record · Phase 2
A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
A Phase 2 study of Chronic Rhinosinusitis With Nasal Polyps, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
- 20
- Study locations
NCT06454240 is a Phase 2 study of Chronic Rhinosinusitis With Nasal Polyps that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 79 participants, below the 135-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06454240, a Phase 2 study of Chronic Rhinosinusitis With Nasal Polyps, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.
Conditions Studied
Interventions
- DRUG placebo
- DRUG lunsekimig
Study Locations (20)
Other
- Investigational Site Number : 0320001 - Buenos Aires
- Investigational Site Number : 0320003 - Mendoza
- Investigational Site Number : 0560002 - Ghent
- Investigational Site Number : 0560001 - Leuven
- Investigational Site Number : 1000001 - Sofia
Texas
- McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017 - Bellaire
- Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004 - Dallas
- Berkson Medical - McKinney- Site Number : 8400014 - McKinney
- Alamo ENT Associates Site Number : 8400001 - San Antonio
California
- Allergy & Rheumatology- Site Number : 8400005 - La Jolla
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003 - Roseville
- Senta Clinic- Site Number : 8400025 - San Diego
Florida
- James A Haley Veterans' Hospital- Site Number : 8400015 - Tampa
Georgia
- Emory University Hospital Midtown- Site Number : 8400012 - Atlanta
Idaho
- The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002 - Boise
Massachusetts
- Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016 - Boston
Oklahoma
- Essential Medical Research- Site Number : 8400020 - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2024-07-17 |
| Est. Completion | 2026-04-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06454240
The ClinicalTrials.gov registry entry for NCT06454240 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (41% lower). 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 2 interventions - of which placebo is the first listed.
NCT06454240 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06454240 about?
NCT06454240 is a clinical study titled "A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps". This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 ...
What is the current status of trial NCT06454240?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2024-07-17. Estimated completion is 2026-04-23.
What conditions does trial NCT06454240 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis With Nasal Polyps.
What interventions are being tested in trial NCT06454240?
The interventions under investigation include: placebo (DRUG), lunsekimig (DRUG).
Who is sponsoring clinical trial NCT06454240?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06454240 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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