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Study on Dupilumab Step-Down Strategy for Maintaining Remission in Adults and Adolescents with Atopic Dermatitis

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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 atopic dermatitis, a common skin condition that causes red, itchy, and inflamed skin. The study is testing a treatment called dupilumab, which is a medication given by injection. Dupilumab is already used to treat atopic dermatitis, and this trial aims to see if changing the frequency of injections can maintain the condition's remission, meaning keeping the symptoms under control, in both adults and adolescents.

The purpose of the study is to compare a new approach of giving dupilumab injections less frequently with the current method of regular injections. Participants in the study will either continue with their regular dupilumab treatment or switch to the new approach. The study will last for one year, during which the participants' skin condition will be monitored to see if the new approach is as effective as the regular treatment in controlling the severity of atopic dermatitis.

Throughout the study, participants will receive either the regular dupilumab treatment or the new step-down strategy, which involves spacing out the injections. The study will help determine if the new strategy can effectively maintain the remission of atopic dermatitis symptoms over the long term. Participants will be closely monitored to ensure their safety and to assess the effectiveness of the treatment strategies.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the clinical trial, you will undergo an initial assessment to confirm your eligibility. This includes verifying that you are at least 12 years old and have been treated with dupilumab every two weeks for at least one year.

    Your atopic dermatitis (AD) must be controlled, with specific scores on the Atopic Dermatitis Control Tool (ADCT) and Investigator Global Assessment (IGA). The amount of topical treatment you use should be stable and less than 60 grams per month.

  2. Step 2

    Treatment phase

    During the treatment phase, you will continue using dupilumab. The trial aims to test a step-down strategy, which means the frequency of your injections may be adjusted.

    You will receive dupilumab as a solution for injection, either 200 mg or 300 mg, administered subcutaneously (under the skin). The exact dosage and frequency will be determined by the trial protocol.

  3. Step 3

    Regular monitoring

    Throughout the trial, your condition will be monitored regularly. This includes weekly assessments of your ADCT score to track the control of your atopic dermatitis over one year.

    Additional evaluations will occur at months 4, 8, and 12, measuring changes in your Eczema Area and Severity Index (EASI) score, Investigator Global Assessment, and itch severity.

  4. Step 4

    End of trial

    At the end of the trial, a final assessment will be conducted to evaluate the long-term control of your atopic dermatitis and the effectiveness of the step-down strategy.

    The trial is expected to conclude by February 15, 2026, at which point all data will be analyzed to determine the outcomes.

Who can join the trial?

6 criteria

  • Age must be 12 years or older.
  • Have moderate to severe atopic dermatitis (a type of skin condition) and currently treated with dupilumab every 2 weeks.
  • Provide written informed consent, which means you agree to participate in the study after understanding all the details. If you are under 18, a parent or guardian must also agree.
  • Have been treated with dupilumab for at least one year.
  • Your atopic dermatitis must be controlled, meaning it is under control and not causing severe symptoms. This is measured by specific scores (ADCT<7 and IGA ≤ 2) and confirmed by a doctor for at least 6 months without changing the dosage of dupilumab.
  • The amount of topical treatment (like creams or ointments) you use should be stable for 6 months and less than 60 grams per month.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with atopic dermatitis cannot participate. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
  • Patients who are not within the specified age range cannot participate. The study is for adolescents and adults.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Dupilumab is a medication used to treat atopic dermatitis, which is a type of eczema that causes red, itchy, and inflamed skin. In this clinical trial, the focus is on finding out if patients can maintain their skin condition with fewer injections over time, compared to the regular treatment schedule. The goal is to see if reducing the frequency of injections can still keep the skin condition under control without making it worse. This medication works by blocking certain proteins in the body that cause inflammation, helping to reduce the symptoms of atopic dermatitis.

What is already known about the treatment

Dupilumab – Dupilumab is administered through an injection, typically under the skin, and is used to treat atopic dermatitis, a type of eczema. It is currently well-regarded in medical literature as an effective treatment for this condition. The main therapeutic use of dupilumab is to help manage and reduce the symptoms of atopic dermatitis, such as itching and inflammation. At the molecular level, dupilumab works by blocking certain proteins in the body that can cause inflammation, helping to calm the immune system's overreaction. It is classified as a monoclonal antibody, which is a type of medication designed to target specific pathways in the immune system.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin may become thickened and cracked over time due to persistent scratching and inflammation. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. The condition is associated with a malfunction in the skin barrier and immune system, leading to increased susceptibility to skin infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501179-23-00Protocol codeRC22_0378Estimated enrolment256 patientsSponsorCentre Hospitalier Universitaire De Nantes

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