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A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
NCT06454240 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, 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 79 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 2 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: NCT06454240 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Texas, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06454240?
The interventions under investigation include: placebo (DRUG), lunsekimig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06454240?
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 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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