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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: Active Phase 2 study of Chronic Rhinosinusitis With Nasal Polyps, sponsored by Sanofi.

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

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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.

Primary Outcome

This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.

Conditions Studied

Chronic Rhinosinusitis With Nasal Polyps

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

FieldValue
Enrollment Target 79 participants
Start Date 2024-07-17
Est. Completion 2026-04-23
Phase Phase 2
Sanofi

713 total trials

What the registry record for NCT06454240 still lists

NCT06454240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 135-participant average among 11 other Chronic Rhinosinusitis With Nasal Polyps trials with a reported enrollment target (41% lower).

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 names 20 study sites across 11 states, led by 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.

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 NCT06454240's enrollment target sits among peer trials

79 6th of 11 higher than 6 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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Related registry views

Source: ClinicalTrials.gov NCT06454240, the US trial registry maintained by the National Library of Medicine. NCT06454240 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.