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Study on the Effects of SAR443765 and Mometasone Furoate in Adults with Chronic Rhinosinusitis with Nasal Polyps

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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 a condition known as chronic rhinosinusitis with nasal polyps (CRSwNP), which affects the respiratory tract. People with this condition often experience ongoing nasal congestion, blockage, or obstruction, and may have a reduced sense of smell or nasal discharge. The study aims to evaluate the effects of a new treatment called lunsekimig, which is given as an injection under the skin, compared to a placebo. The goal is to see how well lunsekimig can reduce the size of nasal polyps and improve symptoms in adults who have not found relief with other treatments.

Participants in the study will receive either lunsekimig or a placebo over a period of time. The study will monitor changes in the size of nasal polyps using a special camera that looks inside the nose, as well as changes in symptoms reported by the participants themselves. These symptoms include nasal congestion, nasal discharge, and loss of smell. The study will also look at how the treatment affects the overall health of the sinuses using imaging techniques like CT scans, which create detailed pictures of the inside of the body.

Throughout the study, researchers will keep track of any side effects or adverse reactions to the treatment. They will also measure the levels of lunsekimig in the blood and check for any immune responses to the drug. The study is designed to provide important information about the safety and effectiveness of lunsekimig for treating CRSwNP, with the hope of offering a new option for people who struggle 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating nasal polyps using a scoring system and reviewing symptoms such as nasal congestion and loss of smell.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving the study medication lunsekimig and the other receiving a placebo. This process is double-blind, meaning neither the participant nor the study team knows which group the participant is in.

  3. Step 3

    Treatment phase

    During the treatment phase, participants receive lunsekimig or a placebo through subcutaneous injection. The frequency and dosage are determined by the study protocol and are administered by healthcare professionals.

  4. Step 4

    Monitoring and assessments

    Regular monitoring and assessments are conducted to evaluate the effect of the treatment. This includes measuring changes in nasal polyps, nasal congestion, and other related symptoms. Participants may also undergo CT scans and complete questionnaires about their symptoms.

  5. Step 5

    Safety evaluations

    Safety evaluations are performed throughout the study to monitor for any adverse effects. This includes checking for treatment-emergent adverse events and serious adverse events.

  6. Step 6

    End of study

    At the end of the study, a final assessment is conducted to evaluate the overall effect of the treatment. Participants may be asked to provide feedback on their experience and any changes in their symptoms.

Who can join the trial?

10 criteria

  • Participants must have a **minimum bilateral nasal polyp score** of 5 out of a maximum score of 8 for both nostrils. This means that each nostril should have at least a score of 2. Nasal polyps are small growths inside the nose that can cause problems with breathing.
  • Participants should have been using **intranasal corticosteroid treatment** for at least 2 months before the screening. These are medications sprayed into the nose to help reduce swelling and irritation.
  • Participants must have ongoing symptoms for at least 2 months before the screening. These symptoms include:
  • **Nasal congestion, blockage, or obstruction** with moderate or severe symptom severity at screening. This means having a stuffy or blocked nose that is quite bothersome.
  • A weekly average severity score of at least 1 at randomization. This score ranges from 0 to 3, where 0 means no symptoms, 1 means mild symptoms, 2 means moderate symptoms, and 3 means severe symptoms.
  • At least one of the following symptoms:
  • **Partial loss of smell (hyposmia)** or **total loss of smell (anosmia)**. This means having trouble smelling things or not being able to smell at all.
  • **Anterior and/or posterior rhinorrhea**. This refers to a runny nose, either from the front or back of the nose.
  • Participants must be adults, which means they should be 18 years or older.
  • Both **male and female** participants are eligible to join the study.

Who cannot join the trial?

5 criteria

  • Participants who have other serious **respiratory tract diseases** that are not related to the study.
  • Individuals who are not adults, as the study is only for adult participants.
  • Participants who have not been diagnosed with **CRSwNP**, which stands for **Chronic Rhinosinusitis with Nasal Polyps**. This is a condition where there are growths in the nose and sinuses that cause problems.
  • Individuals who have their **CRSwNP** well-controlled with current treatments, as the study is for those whose condition is not adequately controlled.
  • Participants who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Lunsekimig is a medication being studied for its potential to help adults with chronic rhinosinusitis with nasal polyps (CRSwNP). This condition involves inflammation of the sinuses and the growth of polyps in the nasal passages, which can lead to symptoms like nasal congestion and difficulty breathing. Lunsekimig is administered as an injection under the skin and is being tested to see if it can reduce the size of nasal polyps and improve symptoms for those whose condition is not well controlled with current treatments.

What is already known about the treatment

Lunsekimig – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials, specifically in a Phase 2 trial, to evaluate its effectiveness and safety for treating chronic rhinosinusitis with nasal polyps. The main therapeutic indication for lunsekimig is respiratory tract diseases, particularly chronic rhinosinusitis with nasal polyps that are not adequately controlled by other treatments. At the molecular level, lunsekimig works by targeting specific pathways involved in inflammation, helping to reduce the size and symptoms of nasal polyps. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) – This is a condition characterized by the inflammation of the nasal passages and sinuses, leading to the growth of soft, painless, noncancerous masses called nasal polyps. These polyps can cause nasal congestion, a reduced sense of smell, and a feeling of fullness in the face. The disease often results in persistent nasal blockage and can affect breathing through the nose. It may also lead to a runny nose and postnasal drip. The condition is chronic, meaning it can last for a long time and may recur after treatment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511261-11-00Protocol codeACT18207Estimated enrolment146 patientsSponsorSanofi-Aventis Recherche & Developpement

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