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New shot could shrink nasal polyps and ease breathing

NCT ID NCT06454240

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called lunsekimig in adults with chronic sinusitis and nasal polyps that persist despite using steroid sprays. The drug is given as a shot under the skin every few weeks. Researchers will measure changes in polyp size and nasal congestion over 24 weeks. The trial includes 79 participants and is already completed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lunsekimig (a drug given as a shot under the skin)
What this could lead to
If it works, this could lead to a new treatment option for people with nasal polyps that are not well controlled with standard sprays.
What could go wrong
This is an early Phase 2 study with only 79 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

Jul 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening Ongoing symptoms for at least 2 months prior to screening, including: * Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe). * At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit * Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery * Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint * Signs or a CT scan suggestive of Allergic fungal rhinosinusitis * Active/chronic helminthic infection * History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit * Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis with nasal polyps

Contacts and locations

Locations

  • Advanced Research Institute - Odgen- Site Number : 8400022

    Ogden, Utah, 84405, United States

  • Alamo ENT Associates Site Number : 8400001

    San Antonio, Texas, 78258, United States

  • Allergy & Rheumatology- Site Number : 8400005

    La Jolla, California, 92037, United States

  • Berkson Medical - McKinney- Site Number : 8400014

    McKinney, Texas, 75070, United States

  • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008

    Norfolk, Virginia, 23510, United States

  • Emory University Hospital Midtown- Site Number : 8400012

    Atlanta, Georgia, 30308, United States

  • Essential Medical Research- Site Number : 8400020

    Tulsa, Oklahoma, 74137, United States

  • Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004

    Dallas, Texas, 75231, United States

  • Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016

    Boston, Massachusetts, 02115, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320003

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Ghent, 9000, Belgium

  • Investigational Site Number : 1000001

    Sofia, 1612, Bulgaria

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 00-909, Poland

  • Investigational Site Number : 6160002

    Krakow, Lesser Poland Voivodeship, 31-033, Poland

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Investigational Site Number : 6160004

    Poznan, 60-693, Poland

  • Investigational Site Number : 6160005

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160007

    Wroclaw, 53-034, Poland

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Investigational Site Number : 8260003

    Manchester, M13 9WL, United Kingdom

  • Investigational Site Number : 8260004

    Gloucester, Gloucestershire, GL1 3NN, United Kingdom

  • James A Haley Veterans' Hospital- Site Number : 8400015

    Tampa, Florida, 33612, United States

  • McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017

    Bellaire, Texas, 77401, United States

  • Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003

    Roseville, California, 95661, United States

  • Senta Clinic- Site Number : 8400025

    San Diego, California, 92018, United States

  • The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002

    Boise, Idaho, 83706, United States

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