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Study on Long-Term Safety and Efficacy of Lunsekimig for Adults with Chronic Rhinosinusitis with Nasal Polyps

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a treatment called lunsekimig for adults with chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a condition where the sinuses become inflamed and develop growths called polyps, which can lead to symptoms like nasal congestion and loss of smell. The treatment being tested, lunsekimig, is a solution for injection that targets specific proteins involved in the inflammation process.

The purpose of this study is to evaluate the long-term safety and tolerability of lunsekimig in participants who have previously completed a related study. Participants will receive lunsekimig injections and continue using their regular nasal spray medication. The study will monitor participants over a period of time to observe any side effects and to assess how well the treatment works in managing their symptoms.

Throughout the study, various assessments will be conducted, including changes in symptom scores and smell tests, as well as measuring the levels of lunsekimig in the blood. The study aims to provide valuable information on the long-term use of lunsekimig for managing CRSwNP, helping to determine its safety and effectiveness for patients with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are required to have completed a previous study involving lunsekimig for chronic rhinosinusitis with nasal polyps (CRSwNP).

    Participants must be currently using an intranasal mometasone furoate nasal spray (MFNS) and be willing to comply with study visits and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the participant's current health status and eligibility for the extension study.

    This assessment includes reviewing the participant's medical history and any previous treatments received.

  3. Step 3

    Treatment administration

    Participants receive lunsekimig as a solution for injection. The specific dosage and frequency are determined by the study protocol.

    The treatment aims to evaluate the long-term safety and tolerability of lunsekimig in managing CRSwNP.

  4. Step 4

    Regular follow-up visits

    Participants attend regular follow-up visits to monitor their response to the treatment and any potential side effects.

    During these visits, various assessments are conducted, including changes in symptoms and overall health status.

  5. Step 5

    Monitoring and evaluation

    The study monitors the incidence of any treatment-emergent adverse events (TEAEs), which are any new or worsening medical issues that occur during the study.

    Secondary evaluations include changes in symptom scores, such as the SNOT-22 total score, rhinosinusitis visual analog scale (VAS), and smell identification test scores.

  6. Step 6

    Completion of the study

    Upon completion of the study, participants undergo a final assessment to evaluate the overall impact of the treatment.

    The study is estimated to conclude by May 6, 2027, with all data collected and analyzed to determine the long-term effects of lunsekimig.

Who can join the trial?

4 criteria

  • Participants must have completed the treatment and follow-up period in the previous study on chronic rhinosinusitis with nasal polyps, including the End of Study (EOS) visit, according to the study protocol.
  • Participants must be receiving treatment with an intranasal spray called mometasone furoate nasal spray (MFNS), which is a medication used to reduce inflammation in the nose.
  • Participants must be able and willing to take part in this extension study and agree to attend the required study visits and follow the study procedures.
  • Participants can be of any gender.

Who cannot join the trial?

8 criteria

  • Patients who do not have chronic rhinosinusitis with nasal polyps cannot participate. This is a condition where the spaces inside your nose and head (sinuses) are swollen and have growths called polyps.
  • Patients who are not adults cannot participate. This means you must be 18 years or older.
  • Patients who are not able to understand or follow the study instructions cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. This means if you have other health issues that could affect the study results, you may not be eligible.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who are participating in another clinical trial cannot participate. This is to avoid any interference with the results of this study.
  • Patients who have had a recent surgery or are planning to have surgery during the study cannot participate. This is to ensure that the surgery does not affect the study results.
  • Patients who have a history of severe allergic reactions cannot participate. This is to ensure your safety during the study.
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Investigated drugs

Lunsekimig is a medication being studied for its potential to help people with chronic rhinosinusitis with nasal polyps, a condition where the sinuses become inflamed and develop growths called polyps. This medication is being tested to see if it can be used safely over a long period and if it can help reduce the symptoms of this condition, which might include nasal congestion, loss of smell, and facial pain. The study aims to understand how well people tolerate the medication and how effective it is in managing their symptoms.

What is already known about the treatment

Lunsekimig – Lunsekimig is administered as an injection, typically given under the skin, to help manage chronic rhinosinusitis with nasal polyps, a condition where the nasal passages become inflamed and swollen. Currently, it is being studied in clinical trials to assess its long-term safety and effectiveness for patients who have not responded well to other treatments. Lunsekimig works by targeting specific molecules in the body that contribute to inflammation, helping to reduce symptoms and improve breathing. It is classified as a biologic medication, which means it is made from living organisms or their cells.

Investigated diseases

Chronic rhinosinusitis with nasal polyps – This condition involves long-term inflammation of the sinuses and nasal passages, often accompanied by the growth of polyps. These polyps are non-cancerous, soft, and painless growths that can obstruct nasal passages, leading to breathing difficulties. The inflammation and polyps can cause symptoms such as nasal congestion, facial pain or pressure, and a reduced sense of smell. Over time, the condition can lead to persistent nasal blockage and frequent sinus infections. The exact cause is not always clear, but it may be related to allergies, infections, or immune system responses. The condition tends to be chronic, meaning it can persist for a long time and may require ongoing management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515912-27-00Protocol codeLTS18300Estimated enrolment74 patientsSponsorSanofi-Aventis Recherche & Developpement

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