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Study to evaluate the long-term safety and effectiveness of lunsekimig in adults with moderate to severe asthma

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 study focuses on individuals living with asthma, a long-term condition that affects the airways in the lungs and can make breathing difficult. The research involves the use of lunsekimig, also known by the code SAR443765, which is administered via subcutaneous injection, meaning the medication is delivered through a needle just under the skin. The goal of this research is to evaluate the long-term safety and effectiveness of this treatment in adults with moderate-to-severe asthma.

Participants in this study are those who previously took part in earlier research trials. During this phase, the medication is given over an extended period to monitor how the body responds over time. This includes watching for any adverse events, which are unwanted or harmful medical occurrences, and observing the frequency of asthma exacerbations, which are sudden worsening of symptoms or attacks. The study also tracks changes in lung function and how the treatment affects daily life and breathing ease.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    You will receive lunsekimig, which is an investigational medication for the treatment of asthma (a condition that affects the airways in the lungs).

    The medication is administered through a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

    This is an open-label extension, meaning the medication being used is known to you and the medical staff.

  2. Step 2

    Long-term monitoring

    The study focuses on evaluating the long-term safety and how well the medication works over an extended period.

    Medical staff will monitor for any adverse events, which are any unexpected or undesirable health changes or side effects that occur during the treatment.

    Your asthma control and quality of life will be assessed using specific questionnaires to track changes in your symptoms and daily activities.

    Your lung function will be measured by checking the forced expiratory volume in 1 second, which is the amount of air you can forcefully exhale in one second.

Who can join the trial?

8 criteria

  • You must have completed a 48-week treatment period in one of two specific previous studies, known as DRI16762 or ACT18301, including the final study visit.
  • You must be using a stable amount of Inhaled Corticosteroids (ICS), which are breathing medicines used to reduce swelling in the airways, at a moderate or high dose.
  • If you were in study DRI16762, you must be taking between one and two other controller medications (daily medicines used to prevent asthma symptoms) such as LABA (long-acting bronchodilators that help open the airways), LAMA (long-acting muscarinic antagonists that also help keep airways open), LTRA (leukotriene receptor antagonists that block chemicals that cause swelling), or methylxanthines (medicines that help relax the muscles in the lungs). This may include or not include oral prednisone, which is a steroid pill used to reduce inflammation.
  • If you were in study ACT18301, you must be taking a LABA (a long-lasting medicine to open airways), either by itself or combined with an LTRA (a medicine that prevents airway swelling).
  • You must be willing and able to take part in the open-label extension study, which is a phase where all participants know which treatment they are receiving, and you must follow all scheduled visits and study tasks.
  • Female participants must not be able to become pregnant, must not be currently pregnant or breastfeeding, and must not be donating or freezing eggs.
  • Male participants must not be donating or freezing sperm.
  • You must be able to provide informed consent, which means you understand the details of the study and sign a document agreeing to participate.

Who cannot join the trial?

10 criteria

  • You cannot join if you have a new health problem or if an existing health problem has changed in a way that the doctor believes would make the study unsafe for you or prevent you from finishing the treatment.
  • You cannot join if you are an employee of the place where the study is being done, or if you are a family member of someone working on the study.
  • You cannot join if you have been diagnosed with a new pulmonary disease, which is a medical condition that affects the lungs and may make it harder for you to breathe.
  • You cannot join if you currently smoke cigarettes, use vaping products, or smoke marijuana.
  • You cannot join if you have a problem with the use of prescription drugs, illegal substances, or alcohol that the doctor considers serious.
  • You cannot join if you have a hypersensitivity or an allergy, which is an extreme immune system reaction, to the study drug or to any of the excipients, which are the inactive ingredients used to make the medicine.
  • You cannot join if you are taking any other medicines that are not allowed during this study.
  • You cannot join if you previously participated in a related study and experienced an AE or an SAE, which stands for an adverse event (an unexpected medical problem) or a serious adverse event (a medical problem that is life-threatening or results in hospitalization) that the doctor believes was caused by the study drug.
  • You cannot join if you are already taking part in any other clinical study.
  • You cannot join if you are living in an institution because of a legal or regulatory order, such as being a prisoner or being legally institutionalized.
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Investigated drugs

Lunsekimig is a medication given as an injection under the skin to help treat asthma by targeting specific parts of the immune system to reduce inflammation.

What is already known about the treatment

Lunsekimig - This medication is administered as an injection under the skin to treat people with asthma. It is currently being studied in clinical trials to determine its long-term safety and effectiveness for managing this breathing condition. As a biological therapy, it works by targeting and blocking specific proteins in the immune system that cause inflammation in the airways. This helps to reduce the swelling and irritation that make it difficult to breathe during an asthma attack.

Investigated diseases

Asthma - This is a long-term condition that affects the airways in the lungs. It causes the tubes that carry air in and out of the lungs to become swollen and narrow. This narrowing often leads to increased mucus production. As the condition progresses, breathing can become difficult, and the airways may react more strongly to certain triggers. These reactions can cause sudden episodes of shortness of breath or coughing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522896-27-00Protocol codeLTS17231Estimated enrolment870 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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