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Study on Stopping Dupilumab in Patients with Severe Asthma Who Have Been on the Drug for Over 3 Years

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on severe asthma, a condition where the airways in the lungs become inflamed and narrowed, making it difficult to breathe. The study examines the effects of stopping a medication called Dupixent (also known as dupilumab), which is used to treat severe asthma. Dupixent is given as a solution for injection under the skin using a pre-filled syringe.

The purpose of the study is to compare the outcomes of patients who stop taking Dupixent with those who continue using it. Participants in the study have been using Dupixent for at least three years and have their asthma well-controlled. The study will observe these patients over a period of 24 months to see if stopping the medication affects their asthma control.

Throughout the study, researchers will monitor the participants' asthma symptoms and any changes in their condition. They will look at factors such as the number of asthma flare-ups, changes in asthma control scores, and whether patients need to restart Dupixent or switch to another treatment. The goal is to understand if stopping Dupixent is as effective as continuing it for patients with well-controlled severe asthma.

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

    Randomization

    Participants are randomly assigned to one of two groups: the intervention group, which stops using dupilumab, or the control group, which continues using dupilumab.

    The purpose is to compare the effects of stopping the medication with continuing it.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish a baseline for asthma control using the asthma control test (ACT) score.

    The ACT score helps measure how well asthma is being managed.

  3. Step 3

    Medication administration

    Participants in the control group continue receiving dupilumab as a subcutaneous injection.

    The medication is administered as a 300 mg solution in a pre-filled syringe.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at 6, 12, and 24 months to monitor asthma control and any changes in the ACT score.

    These assessments help determine if there is a loss of asthma control or any exacerbations.

  5. Step 5

    Monitoring for strategy failure

    Participants are monitored for strategy failure, defined as having two or more asthma exacerbations per year or needing to resume dupilumab or switch to another medication.

    This monitoring continues for 24 months following randomization.

  6. Step 6

    Final evaluation

    A final evaluation is conducted at the end of the 24-month period to assess the overall effectiveness of stopping versus continuing dupilumab.

    The evaluation includes a comparison of asthma control, exacerbations, and any adverse effects experienced by participants.

Who can join the trial?

6 criteria

  • Must be an adult, which means being **18 years old or older**.
  • Must have been treated with **dupilumab** for at least **36 months**. Dupilumab is a medication prescribed by a lung specialist, known as a **pneumologist**, for severe asthma.
  • Must have **well-controlled asthma**. This is determined by an **ACT score** of **18 or higher** and having **0 or 1 asthma flare-up** in the year before joining the study. An ACT score is a way to measure how well asthma is being managed.
  • Must be part of a **social security scheme** or have a similar type of health coverage.
  • Must provide **free, informed, and written consent**. This means agreeing to participate in the study after understanding all the details, and signing a consent form along with the study investigator.
  • Women who can have children must use **effective contraception** to prevent pregnancy during the study.

Who cannot join the trial?

3 criteria

  • Patients with **severe asthma** cannot participate. Severe asthma is a type of asthma that is very difficult to control, even with high doses of medication.
  • Patients who have not been receiving **dupilumab** for at least 36 months cannot participate. Dupilumab is a medication used to treat certain types of asthma.
  • Patients who are part of a **vulnerable population** cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.
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Investigated drugs

Dupilumab is a medication used in the treatment of severe asthma. It works by blocking certain proteins in the body that can cause inflammation, helping to control asthma symptoms. In this clinical trial, the role of dupilumab is to evaluate whether stopping the medication is as effective as continuing it in patients who have been using it for at least 36 months.

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection under the skin, typically in the upper arm, thigh, or abdomen. It is currently used in medicine for the treatment of severe asthma, and its effectiveness is well-documented in medical literature. The main therapeutic indication for Dupilumab is to manage severe asthma, particularly in patients who have not responded well to other treatments. At the molecular level, Dupilumab works by blocking the action of certain proteins involved in the inflammatory response, specifically interleukin-4 and interleukin-13, which play a key role in asthma symptoms. It is classified pharmacologically as a monoclonal antibody, which targets specific pathways in the immune system to reduce inflammation and improve breathing in asthma patients.

Investigated diseases

Severe Asthma – Severe asthma is a chronic respiratory condition characterized by frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. It occurs when the airways in the lungs become inflamed and narrowed, making it difficult to breathe. This form of asthma is more persistent and less responsive to standard treatments compared to milder forms. Patients with severe asthma may experience frequent exacerbations, which are episodes where symptoms worsen significantly. These exacerbations can be triggered by various factors, including allergens, respiratory infections, and environmental irritants. Managing severe asthma often requires a comprehensive approach to control symptoms and prevent exacerbations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516789-13-00Protocol codeRC31/24-0325Estimated enrolment205 patientsSponsorCentre Hospitalier Universitaire De Toulouse

sourced from the EU Clinical Trials Register and site verification

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