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Study on the Effects of Lunsekimig (SAR443765) in Adults with High-Risk Asthma Not Eligible for Biologic Treatment

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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 asthma, a condition that affects the airways in the lungs, making it difficult to breathe. The study is testing a new treatment called lunsekimig, also known by its code name SAR443765. This treatment is given as a solution for injection under the skin. The trial will compare the effects of lunsekimig with a placebo to see how well it works in reducing asthma flare-ups in adults who have high-risk asthma and are not currently eligible for other biologic treatments.

The purpose of the study is to evaluate how effective lunsekimig is in preventing asthma exacerbations, which are episodes where asthma symptoms become much worse. Participants in the study will receive either the lunsekimig injection or a placebo and will be monitored over a period of time to see how their asthma symptoms change. The study will also look at other factors, such as lung function, asthma control, and quality of life, to get a comprehensive understanding of the treatment's impact.

Throughout the study, researchers will collect information on any side effects experienced by participants, as well as how the body responds to the treatment. This will help determine the safety and tolerability of lunsekimig. The study aims to provide valuable insights into whether this new treatment can offer a beneficial option for people with high-risk asthma who have limited treatment choices.

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

    The trial begins with an initial assessment to confirm eligibility. This includes a review of asthma history and a lung function test to measure the forced expiratory volume in one second (FEV1).

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving the lunsekimig (SAR443765) treatment and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment.

  3. Step 3

    Treatment administration

    The treatment involves a subcutaneous injection of either lunsekimig or placebo. The frequency and dosage are determined by the study protocol and are administered regularly throughout the trial.

  4. Step 4

    Monitoring and follow-up

    Participants attend regular follow-up visits to monitor asthma symptoms, lung function, and any side effects. These visits include assessments such as the Asthma Control Questionnaire and lung function tests.

  5. Step 5

    Data collection

    Data on asthma exacerbations, lung function changes, and quality of life are collected throughout the trial. This includes tracking the annualized rate of asthma exacerbation events and changes in asthma control.

  6. Step 6

    End of trial

    The trial concludes with a final assessment to evaluate the overall efficacy and safety of lunsekimig compared to placebo. Participants may be asked to provide feedback on their experience during the trial.

Who can join the trial?

6 criteria

  • You must have been diagnosed by a doctor with **mild-to-moderate asthma** for more than 12 months. This diagnosis should follow the **GINA guidelines**, which are international rules for managing asthma.
  • You should have had at least one **asthma exacerbation** in the year before the first screening visit. An asthma exacerbation is a worsening of asthma symptoms that may require extra treatment.
  • Your **Pre-BD FEV1** should be equal to or more than 40% of what is considered normal for your age and size. **Pre-BD FEV1** is a measure of how much air you can forcefully exhale in one second before using a bronchodilator, which is a medicine that helps open your airways.
  • You should be between the ages of 3 and 4 years old.
  • Both males and females can participate in the study.
  • The study includes people who may be considered vulnerable, meaning they might need extra care or protection.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of asthma cannot participate. Asthma is a condition that affects the airways in the lungs, making it hard to breathe.
  • Participants must be within a certain age range, specifically between 18 and 65 years old.
  • Both males and females are eligible, so gender does not exclude participation.
  • People who are considered part of a vulnerable population may not be eligible. This term refers to groups who might need special protection, like children, pregnant women, or those with certain disabilities.
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Investigated drugs

Lunsekimig (SAR443765) is a medication being studied for its potential to help people with high-risk asthma. This medication is given as an injection under the skin. The trial aims to see if it can reduce asthma attacks in adults who have severe asthma but cannot currently use other biologic treatments.

What is already known about the treatment

Lunsekimig – This medication is administered subcutaneously, meaning it is injected under the skin. Currently, it is being studied in clinical trials and is not yet widely available in medical practice. Lunsekimig is being investigated for its potential to treat high-risk asthma in adults who are not eligible for existing biologic treatments. It works by targeting specific pathways involved in the inflammatory process associated with asthma, aiming to reduce the frequency and severity of asthma attacks. Lunsekimig falls under the pharmacological classification of biologic agents, which are typically derived from living organisms and used to target specific components of the immune system.

Investigated diseases

Asthma – Asthma is a chronic condition that affects the airways in the lungs, causing them to become inflamed and narrow. This leads to symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity and frequency of these symptoms can vary from person to person. Asthma can be triggered by various factors, including allergens, exercise, cold air, and stress. Over time, repeated asthma attacks can lead to changes in the airways, making them more sensitive and reactive. Managing asthma involves avoiding triggers and monitoring symptoms to prevent exacerbations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513959-33-00Protocol codeACT18301Estimated enrolment2 468 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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