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Atopic DermatitisPhase 4MADULONCT05642208

Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis

A Phase 4 study testing Dupilumab step-down in people with Atopic Dermatitis and Eczema, Atopic, run by Nantes University Hospital at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis, Eczema, Atopic
What is being tested?
Dupilumab step-down
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
32 sitesin 2 countries
Study dates
8 Mar 2023to 27 Aug 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 12 years
  • Moderate to severe AD treated with dupilumab every 2 weeks
  • Written informed consent (patient and/or person who has parental authority)
  • Dupilumab treatment for at least one year
  • Controlled AD (ADCT<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab
  • Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month

Who cannot join

  • Patients with Side effects of dupilumab
  • Non controlled AD: ADCT ≥ 7 or IGA ≥ 3
  • Female patient must not be pregnant*, breastfeeding or considering becoming pregnant
  • Patient under judicial protection
  • Adults under guardianship or trusteeship

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

France31 sites

  • Amiens University hospital

    Amiens

  • CHU d'Angers

    Angers

  • Hôpital Victor Dupouy

    Argenteuil

  • CHU de Besançon

    Besançon

  • CHU de Bordeaux Adulte

    Bordeaux

  • CHRU de Brest

    Brest

  • CHU de Clermont Ferrand

    Clermont-Ferrand

  • CHU de Dijon

    Dijon

  • CHU de Grenoble

    Grenoble

  • CHD Vendée

    La Roche-sur-Yon

  • GH La Rochelle - Ré-Aunis

    La Rochelle

  • CH de Le Mans

    Le Mans

  • CHRU de Lille

    Lille

  • Groupement des Hôpitaux de l'institut Catholique de Lille

    Lille

  • Hospices Civils de Lyon

    Lyon

  • Hôpital de la Timone

    Marseille

  • CHU de Montpellier

    Montpellier

  • CHU de Nantes

    Nantes

  • CH de Niort

    Niort

  • Hôpital Cochin

    Paris

  • Hôpital Necker-Enfants malades

    Paris

  • Hôpital Saint Louis

    Paris

  • Hôpital Tenon

    Paris

  • CHU de Poitiers

    Poitiers

  • CHU de Reims

    Reims

  • CHU de Rennes

    Rennes

  • CHU de Rouen

    Rouen

  • CH de Saint Nazaire

    Saint-Nazaire

  • HIA Sainte Anne

    Toulon

  • CHU de Toulouse - Hôpital Larrey

    Toulouse

  • CHRU de Tours

    Tours

Other trials in France

Reunion1 site

  • CHU de La Réunion

    Saint-Pierre, La Réunion

Other trials in Reunion

About this study

Official title: Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial

The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

Read the detailed description

For both groups:

At inclusion visit :

  • Patient information and signature of consent form
  • Randomisation
  • Previous medical history
  • Clinical exam
  • Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L

Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) :

  • Self-assessment of ADCT
  • Date of dupilumab injections
  • Batch number of dupilumab
  • Amount of topical corticosteroids

Visits at M4, M8 and M12 will be performed for :

  • Clinical exam
  • Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events
  • Collect out-of-pocket expenses (M4 and M12).
Being tested
Dupilumab step-down
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab step-downDrug

    step down dupilumab injections

Study groups in NCT05642208
Study groupRoleWhat they receive
Experimental GroupExperimentalInjections will be spaced as : * Every 3 weeks between M0 and M4, * Every 4 weeks between M4 and M8 (if ADCT<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used), * Then every 5 weeks until the end of the clinical trial (M12) (if ADCT<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used). In case of ADCT≥7 or IGA > 2 or disease assessed as uncontrolled by the investigator, the injection interval treatment will be step up to the previous interval. The treatment is administered subcutaneously and can be delivered in pen or syringe for subcutaneous injection. The dosage is usually : * 300 mg per injection for adults and adolescents (12-17 years) weighing more than 60 kg * 200 mg per injection for adolescents (12-17 years) weighing less than 60 kg.
Receives: Drug: Dupilumab step-down
Control groupNo interventionin this group the interval between injections is maintained every 2 weeks (14 days) throughout the clinical trial. The treatment is administered subcutaneously and can be delivered in pen or syringe for subcutaneous injection. Treatment will be prescribed in the control group according to the marketing authorization dosage (see paragraph 5.1). The dosage is usually : * 300 mg every 14 days for adults and adolescents (12-17 years) weighing more than 60 kg * 200 mg every 14 days for adolescents (12-17 years) weighing less than 60 kg.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve of Atopic Dermatitis Control Tool (ADCT)

    to demonstrate the non-inferiority of a step down dosage strategy of dupilumab as compared with maintenance of initial treatment, on long-term control of the disease severity at one year in adolescents and adults patients with controlled AD.The primary endpoint is the Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved by the patient every week during one year.

    As the ADCT score refers to the last 7 days, a weekly assessment is the most accurate to detect all variations in disease severity intensity.

    Measured: over 12 months

Secondary outcomes (6)

  1. Mean difference in EASI score

    to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Eczema Area and Severity Index Mean difference in EASI score from baseline to month 4, month 8, month 12(EASI)

    Measured: every 4 months over 12 months

  2. Mean difference in Investigator global assessment

    to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Investigator Global assessment (IGA) Mean difference in Investigator global assessment from baseline to month 4, month 8, month 12

    Measured: every 4 months over 12 months

  3. Mean difference in Itch numerical rating scale

    to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Itch numerical rating scale Mean difference in Itch numerical rating scale from baseline to month 4, month 8, month 12

    Measured: every 4 months over 12 months

  4. The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at M4, M8, M12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children <16)

    The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at month 4, month 8, month 12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children <16) from baseline to month 4, month 8, month 12 will be assessed.

    to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the patient quality of life.

    Measured: every 4 months over 12 months

  5. cost-utility analysis performed from a health care system perspective

    The economic efficiency will be assessed by a cost-utility analysis performed from a health care system perspective (i.e. considering only direct health care costs) and a 1-year time horizon. Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective and with a 1-year time horizon will be taken into account.

    to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the economic efficiency

    Measured: over 12 months

  6. Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective

    The economic efficiency will be assessed by a cost-utility analysis performed from a health care system perspective (i.e. considering only direct health care costs) and a 1-year time horizon. Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective and with a 1-year time horizon will be taken into account.

    to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the economic efficiency

    Measured: over 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2022
  2. Study start8 Mar 2023
  3. Primary completion27 Aug 2026
  4. Study completion27 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05642208
Sponsor's protocol ID
RC22_0378
Acronym
MADULO
Status last verified
Sep 2026
First submitted
29 Nov 2022
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Foureau A, Faurel-Paul E, Hardouin JB, Papinot L, Schirr-Bonnans S, Tessier P, Jobert A, Poinas A, Staumont-Salle D, Tauber M, Chosidow O, Barbarot S, Aubert H; the FRench Atopic DErmatitis Network from de GREAT Research group. Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO). Trials. 2025 Dec 5;27(1):26. doi: 10.1186/s13063-025-09325-4.

    PubMed 41350756

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dupilumab step-down in people with Atopic Dermatitis and Eczema, Atopic, run by Nantes University Hospital at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in France, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve of Atopic Dermatitis Control Tool (ADCT) (time frame: over 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05642208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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