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Study of Different Doses of Amlitelimab Given by Injection Under the Skin in Adults with Moderate to Severe Asthma

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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 treating patients with moderate-to-severe asthma, a condition where airways become inflamed and narrow, making breathing difficult. The research evaluates a new medication called amlitelimab, which is given as a subcutaneous injection (an injection under the skin). The study aims to determine how well different doses of amlitelimab work compared to placebo in people whose asthma is not well controlled with their current treatments.

The medication being tested, amlitelimab (also known as SAR445229), is a new type of medicine that targets specific components of the immune system that may be involved in asthma. During the study, participants will receive either amlitelimab or placebo injections over a period of 48 weeks. The maximum single dose that may be given is 500 milligrams, with a total possible amount of 2,750 milligrams over the entire treatment period.

Throughout the study, doctors will monitor how well the treatment works by tracking various aspects of participants' asthma, including how often they experience severe asthma attacks, their breathing capacity, and how well they can control their symptoms. They will also keep track of any side effects that may occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period start

    You will begin receiving either amlitelimab or a placebo through subcutaneous injection (injection under the skin).

    Your current asthma medications will continue throughout the study period.

  2. Step 2

    Regular assessment visits

    Your asthma will be monitored at weeks 2, 4, 8, 12, 16, 24, 36, and 48.

    During these visits, several measurements will be taken:

    - Breathing tests to measure lung function (FEV1 - amount of air you can exhale in one second)

    - Completion of questionnaires about your asthma symptoms and quality of life

    - Measurement of exhaled nitric oxide (FeNO) - a marker of airway inflammation

    Blood samples will be collected to measure medication levels and check for antibodies

  3. Step 3

    Daily monitoring

    You will need to record your asthma symptoms in the morning and evening

    Track your use of rescue medications (quick-relief inhalers)

    Note any worsening of asthma symptoms or attacks

  4. Step 4

    48-week evaluation

    A comprehensive assessment will be performed to evaluate:

    - Changes in your lung function

    - Number of severe asthma attacks during the study period

    - Overall asthma control

    - Quality of life improvements

  5. Step 5

    Final follow-up

    Additional monitoring will continue until week 60

    Final assessments of your asthma control and medication effects will be performed

    Safety monitoring will be conducted throughout the entire study period

Who can join the trial?

8 criteria

  • Must be aged between 18 and 75 years old when signing the consent form
  • Must have been diagnosed with moderate to severe asthma by a doctor for at least 12 months
  • Must be currently using high-dose inhaled corticosteroids (a type of asthma medication) along with at least one other asthma controller medication for at least 3 months
  • Must have experienced at least one severe asthma attack in the past year while using high-dose inhaled corticosteroids
  • Must have a lung function test (FEV1) result between 40% and 80% of normal predicted value
  • Must have an ACQ-5 score (a questionnaire that measures asthma control) greater than 1.5
  • Must show improvement in lung function of at least 12% and 200mL after using a rescue inhaler, or have documentation of this improvement in the past
  • Must weigh between 40 kg and 150 kg (88-330 pounds)

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Current smokers or those who quit smoking less than 6 months ago
  • Diagnosis of other serious lung conditions besides asthma
  • Use of biological therapy (specialized medications that target specific parts of the immune system) in the past 4 months
  • Serious heart, liver, or kidney disease
  • Active respiratory infection (infection affecting the lungs or airways)
  • Participation in other clinical trials within the past 30 days
  • Inability to perform breathing tests properly
  • History of life-threatening asthma attacks in the past 12 months
  • Uncontrolled high blood pressure
  • History of cancer in the past 5 years (except treated skin cancer)
  • Known immune system disorders
  • Regular use of oral steroids for conditions other than asthma
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Investigated drugs

Amlitelimab is an investigational medication administered by subcutaneous injection (under the skin) for treating moderate to severe asthma. It is being studied as a potential treatment option for patients whose asthma symptoms are not well controlled with their current medications. This medication works by targeting specific components of the immune system involved in asthma inflammation.

What is already known about the treatment

Amlitelimab - A novel investigational medication administered through subcutaneous injection for the treatment of moderate-to-severe asthma. This biological agent belongs to the class of targeted immunotherapy medications and is currently being evaluated in clinical trials to assess its efficacy, safety, and tolerability in adult patients with uncontrolled asthma. The drug works by modulating specific immune system pathways involved in asthma inflammation, though its exact molecular mechanism of action is still being studied through ongoing research. Amlitelimab represents a potential new treatment option for patients whose asthma symptoms are not adequately controlled with conventional therapies.

Investigated diseases

Asthma - A chronic respiratory condition that affects the airways in the lungs, causing them to become inflamed and narrow. The airways become sensitive and react strongly to certain triggers, such as allergens, exercise, cold air, or stress. During an asthma episode, the muscles around the airways tighten, the airways become swollen, and more mucus is produced, making it difficult to breathe. Common symptoms include wheezing, coughing, shortness of breath, and chest tightness. The severity of symptoms can vary from mild to severe, and they may come and go over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510641-33-00Protocol codeDRI17509Estimated enrolment408 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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