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

Atopic Dermatitis Clinical Trial

— MADULO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642208
• Other study ID #: RC22_0378
• Status: Recruiting
• Phase: Phase 4
• Start date: March 8, 2023
• Est. completion date: March 8, 2026

Study information

• Verified date: March 2024
• Source: Nantes University Hospital
• Contact: Elodie FAUREL-PAUL
• Phone: +33 (0) 2 44 76 81 44
• Email: Elodie.FAURELPAUL[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: March 8, 2026
• Est. primary completion date: March 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema, Atopic

Intervention

Drug:
• Dupilumab step-down
step down dupilumab injections

Locations

Country	Name	City	State
France	CHU d'Angers	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
Réunion	CHU de La Réunion	Saint-Pierre	La Réunion

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Countries where clinical trial is conducted

France,  Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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