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New drug shows promise for Hard-to-Treat nasal polyps

NCT ID NCT06914908

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study looks at the long-term safety and effectiveness of lunsekimig, an injectable drug, in adults with chronic sinusitis and nasal polyps that are not well controlled. Participants have already completed a previous lunsekimig study and will continue treatment for up to 52 weeks. The goal is to see if the drug remains safe and helps control symptoms over time.

What this could mean

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

Active substance
lunsekimig (injection) and mometasone furoate nasal spray
What this could lead to
If successful, this could provide a long-term treatment option for people with nasal polyps that are not well controlled by current therapies.
What could go wrong
This is a small, early-phase extension study with no placebo group, so results may not confirm effectiveness. Side effects are still being evaluated.

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

About 71 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

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 years and older

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: * Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol * Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS) * Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alamo ENT Associates- Site Number : 8400001

    San Antonio, Texas, 78258, United States

  • ENT Associates of Texas - McKinne- Site Number : 8400014

    McKinney, Texas, 75070, United States

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

    Norfolk, Virginia, 23510, United States

  • Essential Medical Research- Site Number : 8400020

    Tulsa, Oklahoma, 74137, 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, 30-033, Poland

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6160005

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160007

    Wroclaw, Lower Silesian Voivodeship, 50-750, 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

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

    Bellaire, Texas, 77401, United States

  • Modena Allergy + Asthma- Site Number : 8400005

    La Jolla, California, 92037, United States

  • Pharmaceutical Research & Consulting- Site Number : 8400004

    Dallas, Texas, 75231, United States

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

    Roseville, California, 95661, United States

  • Treasure Valley Medical Research- Site Number : 8400002

    Boise, Idaho, 83706, United States

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