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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.
For both groups:
At inclusion visit :
Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) :
Visits at M4, M8 and M12 will be performed for :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Injections will be spaced as :
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 :
|
|
| Control group | No Intervention | in 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 :
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab step-down | Drug | step down dupilumab injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | over 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | every 4 months over 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène AUBERT | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens University hospital | Amiens | France | ||||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41350756 | Derived | 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. |
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| 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 | every 4 months over 12 months |
| 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 | every 4 months over 12 months |
| 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. | every 4 months over 12 months |
| 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 | over 12 months |
| 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 | over 12 months |
| Angers |
| France |
| Hôpital Victor Dupouy | Argenteuil | France |
| CHU de Besançon | Besançon | France |
| CHU de Bordeaux Adulte | Bordeaux | France |
| CHRU de Brest | Brest | France |
| CHU de Clermont Ferrand | Clermont-Ferrand | France |
| CHU de Dijon | Dijon | France |
| CHU de Grenoble | Grenoble | France |
| CHD Vendée | La Roche-sur-Yon | France |
| GH La Rochelle - Ré-Aunis | La Rochelle | France |
| CH de Le Mans | Le Mans | France |
| CHRU de Lille | Lille | France |
| Groupement des Hôpitaux de l'institut Catholique de Lille | Lille | France |
| Hospices Civils de Lyon | Lyon | France |
| Hôpital de la Timone | Marseille | France |
| CHU de Montpellier | Montpellier | France |
| CHU de Nantes | Nantes | France |
| CH de Niort | Niort | France |
| Hôpital Cochin | Paris | France |
| Hôpital Necker-Enfants malades | Paris | France |
| Hôpital Saint Louis | Paris | France |
| Hôpital Tenon | Paris | France |
| CHU de Poitiers | Poitiers | France |
| CHU de Reims | Reims | France |
| CHU de Rennes | Rennes | France |
| CHU de Rouen | Rouen | France |
| CH de Saint Nazaire | Saint-Nazaire | France |
| HIA Sainte Anne | Toulon | France |
| CHU de Toulouse - Hôpital Larrey | Toulouse | France |
| CHRU de Tours | Tours | France |
| CHU de La Réunion | Saint-Pierre | La Réunion | Reunion |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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