Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Long-Term Safety and Efficacy of Amlitelimab for Adults with Moderate to Severe Asthma

Verified siteFast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 will use a treatment called amlitelimab, which is a solution for injection. Amlitelimab is a novel human anti-OX40L monoclonal antibody, which is a type of protein designed to help manage asthma symptoms. The study will also include a matched placebo for comparison purposes.

The purpose of this study is to evaluate the long-term safety and effectiveness of amlitelimab in adults with moderate to severe asthma who have already completed a previous amlitelimab asthma study. Participants will receive the treatment through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants over an extended period to assess how well they tolerate the treatment and its impact on their asthma symptoms.

Throughout the study, researchers will keep track of any side effects or adverse events that participants may experience. They will also measure changes in lung function and asthma control to determine the treatment's effectiveness. This information will help in understanding how amlitelimab can be used to manage asthma in the long term.

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 will be informed about the purpose and procedures of the trial. This study aims to evaluate the long-term safety and effectiveness of a medication called amlitelimab for individuals with moderate-to-severe asthma.

  2. Step 2

    Medication administration

    Participants will receive amlitelimab through a subcutaneous injection, which means the medication is injected under the skin. The specific dosage and frequency of administration will be determined by the study protocol and communicated to participants by the study team.

  3. Step 3

    Ongoing asthma treatment

    Participants will continue their existing asthma treatment, which includes medium-to-high doses of inhaled corticosteroids (ICS) such as fluticasone propionate, in combination with other asthma control medications. These may include long-acting beta agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or methylxanthines. Some participants may also use oral corticosteroids (OCS) as part of their treatment.

  4. Step 4

    Safety and health monitoring

    Throughout the study, participants will be regularly monitored for any side effects or health changes. This includes tracking any adverse events that occur during the treatment period. Participants will be asked to report any new or unusual symptoms to the study team.

  5. Step 5

    Asthma control assessment

    Participants will undergo regular assessments to evaluate their asthma control. This may include tests to measure lung function, such as spirometry, and completing questionnaires about asthma symptoms and quality of life.

  6. Step 6

    Study duration

    The study is expected to continue until October 2030. Participants will be informed about the specific duration of their involvement in the study and any follow-up visits required after the treatment period.

Who can join the trial?

7 criteria

  • Participants must have moderate-to-severe asthma and have completed the treatment period of the previous study as required.
  • Participants must be taking a background dose of medium-to-high doses of inhaled corticosteroids (ICS). This means at least 500 micrograms of fluticasone propionate daily or a similar dose, up to a maximum of 2000 micrograms per day, along with a second or third controller medication. These controller medications can include:
    • LABA (long-acting beta agonists)
    • LTRA (leukotriene receptor antagonists)
    • LAMA (long-acting muscarinic antagonists)
    • Methylxanthines
    • Participants must agree to use contraception:
      • For female participants: They must be incapable of becoming pregnant, not pregnant or breastfeeding, and must not donate or preserve eggs.
      • For male participants: They must not donate or preserve sperm.

Who cannot join the trial?

10 criteria

  • Participants with any other serious health conditions that could interfere with the study.
  • Participants who have had a recent infection that required treatment with antibiotics.
  • Participants who have been diagnosed with cancer in the past five years.
  • Participants who are currently pregnant or breastfeeding.
  • Participants who have a history of severe allergic reactions.
  • Participants who are currently using other medications that might interfere with the study treatment.
  • Participants who have participated in another clinical trial within the last 30 days.
  • Participants who have a history of drug or alcohol abuse.
  • Participants who have a known sensitivity or allergy to the study medication.
  • Participants who have a condition that affects their immune system, which is the body's defense against infections.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Amlitelimab is a medication being studied for its potential to help people with moderate-to-severe asthma. It is given as an injection under the skin. The main goal of using amlitelimab in this study is to see if it is safe and well-tolerated when used for a long time. Researchers also want to find out if it can effectively help manage asthma symptoms over an extended period. Participants in this study have already completed a previous study with amlitelimab, and this trial aims to continue monitoring its effects on their asthma.

What is already known about the treatment

Amlitelimab – Amlitelimab is administered as an injection under the skin, known as a subcutaneous injection. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating moderate-to-severe asthma. The main therapeutic use of amlitelimab is to help manage asthma symptoms in adults who have already participated in previous studies of this medication. At the molecular level, amlitelimab works by targeting specific proteins in the immune system to reduce inflammation, which is a key factor in asthma. It is classified as an immunomodulatory drug, meaning it helps regulate the immune system's activity.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The disease can progress with episodes known as asthma attacks, where symptoms become more severe and require immediate attention. These attacks can be triggered by various factors, including allergens, exercise, cold air, or stress. Over time, asthma can lead to changes in the airways, making them more sensitive and reactive. The condition requires ongoing management to control symptoms and prevent exacerbations.
Trial detailsLast updated 16 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503385-24-00Protocol codeLTS17510Estimated enrolment335 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.