Clinical trial NCT05642208: Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
Official title: Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Eczema, Atopic
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 256
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve of Atopic Dermatitis Control Tool (ADCT)
timeFrame: over 12 months
Secondary outcomes:
measure: Mean difference in EASI score
timeFrame: every 4 months over 12 months
measure: Mean difference in Investigator global assessment
timeFrame: every 4 months over 12 months
measure: Mean difference in Itch numerical rating scale
timeFrame: every 4 months over 12 months
measure: 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)
timeFrame: every 4 months over 12 months
measure: cost-utility analysis performed from a health care system perspective
timeFrame: over 12 months
measure: Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective
timeFrame: over 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University hospital
city: Angers
country: France
facility: CHU d'Angers
city: Argenteuil
country: France
facility: Hôpital Victor Dupouy
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux Adulte
city: Brest
country: France
facility: CHRU de Brest
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: GH La Rochelle - Ré-Aunis
city: Le Mans
country: France
facility: CH de Le Mans
city: Lille
country: France
facility: CHRU de Lille
city: Lille
country: France
facility: Groupement des Hôpitaux de l'institut Catholique de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Niort
country: France
facility: CH de Niort
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Necker-Enfants malades
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Tenon
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Nazaire
country: France
facility: CH de Saint Nazaire
city: Toulon
country: France
facility: HIA Sainte Anne
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Tours
country: France
facility: CHRU de Tours
city: Saint-Pierre
country: Réunion
facility: CHU de La Réunion
state: La Réunion
Study officials:
affiliation: Nantes University Hospital
name: Hélène AUBERT
role: PRINCIPAL_INVESTIGATOR
References: