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
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amiens University Hospital Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Hôpital Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil | France | Unknown status |
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| CHU de Bordeaux Adulte Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHRU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU de DIJON Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| GH La Rochelle - Ré-Aunis Coordinator of this site? Confirm its status | La Rochelle | France | Unknown status |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| CH de Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| CHRU de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CH de Niort Coordinator of this site? Confirm its status | Niort | France | Unknown status |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CHU de Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU de Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CH de Saint Nazaire Coordinator of this site? Confirm its status | Saint-Nazaire | France | Unknown status |
| Hia Sainte Anne Coordinator of this site? Confirm its status | Toulon | France | Unknown status |
| CHU de Toulouse - Hopital Larrey Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| CHU de La Réunion Coordinator of this site? Confirm its status | Saint-Pierre | Réunion | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.