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NCT05642208CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
256 (actual)
First submitted
29 Nov 2022
Start date
8 Mar 2023
Primary completion date
27 Aug 2026
Lead sponsor
Nantes University Hospital
NCT number
NCT05642208

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 256
  • From 8 Mar 2023 to the primary completion date, 27 Aug 2026
  • 32 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amiens University Hospital
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AmiensFranceUnknown status
CHU d Angers
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AngersFranceUnknown status
Hôpital Victor Dupouy
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ArgenteuilFranceUnknown status
CHU de Besançon
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BesançonFranceUnknown status
CHU de Bordeaux Adulte
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BordeauxFranceUnknown status
CHRU de Brest
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BrestFranceUnknown status
CHU de Clermont-Ferrand
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Clermont-FerrandFranceUnknown status
CHU de DIJON
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DijonFranceUnknown status
CHU de Grenoble
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GrenobleFranceUnknown status
GH La Rochelle - Ré-Aunis
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La RochelleFranceUnknown status
CHD Vendée
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La Roche-sur-YonFranceUnknown status
CH de Le Mans
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Le MansFranceUnknown status
CHRU de Lille
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LilleFranceUnknown status
Groupement Des Hopitaux De L'Institut Catholique De Lille
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LilleFranceUnknown status
Hospices Civils de Lyon
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LyonFranceUnknown status
Hopital de la Timone
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MarseilleFranceUnknown status
CHU de Montpellier
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MontpellierFranceUnknown status
CHU de Nantes
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NantesFranceUnknown status
CH de Niort
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NiortFranceUnknown status
Hopital Necker Enfants Malades
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ParisFranceUnknown status
Hôpital Tenon
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ParisFranceUnknown status
Hôpital Cochin
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ParisFranceUnknown status
Hopital Saint Louis
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ParisFranceUnknown status
CHU de Poitiers
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PoitiersFranceUnknown status
CHU de Reims
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ReimsFranceUnknown status
CHU de Rennes
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RennesFranceUnknown status
CHU de Rouen
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RouenFranceUnknown status
CH de Saint Nazaire
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Saint-NazaireFranceUnknown status
Hia Sainte Anne
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ToulonFranceUnknown status
CHU de Toulouse - Hopital Larrey
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ToulouseFranceUnknown status
CHRU de Tours
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ToursFranceUnknown status
CHU de La Réunion
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Saint-PierreRéunionUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.