Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
NCT ID: NCT05642208
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
256 participants
INTERVENTIONAL
2023-03-08
2026-09-08
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group
Injections 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.
Dupilumab step-down
step down dupilumab injections
Control group
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 :
* 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.
No interventions assigned to this group
Interventions
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Dupilumab step-down
step down dupilumab injections
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hélène AUBERT
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Amiens University hospital
Amiens, , 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, , France
CHU de La Réunion
Saint-Pierre, La Réunion, Reunion
Countries
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Other Identifiers
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RC22_0378
Identifier Type: -
Identifier Source: org_study_id
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