Using a step-down approach with dupilumab to maintain remission in atopic dermatitis patients
Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial
PHASE4 · Nantes University Hospital · NCT05642208
This study is testing if giving dupilumab injections less often can help teenagers and adults with controlled atopic dermatitis stay in remission just as well as the usual treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Drugs / interventions | dupilumab |
| Locations | 32 sites (Amiens and 31 other locations) |
| Trial ID | NCT05642208 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a step-down strategy for administering dupilumab injections compared to standard maintenance treatment in adolescents and adults with controlled atopic dermatitis. Participants will be randomly assigned to either the step-down group or the standard treatment group after providing informed consent. The study will involve regular assessments of atopic dermatitis severity and treatment adherence over a 12-month period, utilizing various clinical evaluation tools. The primary endpoint will focus on the area under the curve of the weekly Atopic Dermatitis Control Tool (ADCT) assessment.
Who should consider this trial
Good fit: Ideal candidates are adolescents and adults aged 12 years and older with moderate to severe atopic dermatitis who have been on dupilumab treatment for at least one year and have maintained controlled symptoms.
Not a fit: Patients with uncontrolled atopic dermatitis or those who have experienced side effects from dupilumab may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients maintain remission while potentially reducing the frequency of dupilumab injections.
How similar studies have performed: Other studies have explored similar treatment strategies with dupilumab, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 31 other locations
- Amiens University hospital — Amiens, France (NOT_YET_RECRUITING)
- CHU d'Angers — Angers, France (RECRUITING)
- Hôpital Victor Dupouy — Argenteuil, France (TERMINATED)
- CHU de Besançon — Besançon, France (RECRUITING)
- CHU de Bordeaux Adulte — Bordeaux, France (RECRUITING)
- CHRU de Brest — Brest, France (RECRUITING)
- CHU de Clermont Ferrand — Clermont-Ferrand, France (RECRUITING)
- CHU de Dijon — Dijon, France (RECRUITING)
- CHU de Grenoble — Grenoble, France (RECRUITING)
- CHD Vendée — La Roche-sur-Yon, France (RECRUITING)
- GH La Rochelle - Ré-Aunis — La Rochelle, France (RECRUITING)
- CH de Le Mans — Le Mans, France (RECRUITING)
- CHRU de Lille — Lille, France (RECRUITING)
- Groupement des Hôpitaux de l'institut Catholique de Lille — Lille, France (TERMINATED)
- Hospices Civils de Lyon — Lyon, France (RECRUITING)
- Hôpital de la Timone — Marseille, France (RECRUITING)
- CHU de Montpellier — Montpellier, France (RECRUITING)
- CHU de Nantes — Nantes, France (RECRUITING)
- CH de Niort — Niort, France (RECRUITING)
- Hôpital Cochin — Paris, France (RECRUITING)
- Hôpital Necker-Enfants malades — Paris, France (RECRUITING)
- Hôpital Saint Louis — Paris, France (RECRUITING)
- Hôpital Tenon — Paris, France (RECRUITING)
- CHU de Poitiers — Poitiers, France (RECRUITING)
- CHU de Reims — Reims, France (TERMINATED)
- CHU de Rennes — Rennes, France (RECRUITING)
- CHU de Rouen — Rouen, France (RECRUITING)
- CH de Saint Nazaire — Saint-Nazaire, France (RECRUITING)
- HIA Sainte Anne — Toulon, France (RECRUITING)
- CHU de Toulouse - Hôpital Larrey — Toulouse, France (RECRUITING)
- CHRU de Tours — Tours, France (RECRUITING)
- CHU de La Réunion — Saint-Pierre, La Réunion, Réunion (RECRUITING)
Study contacts
- Principal investigator: Hélène AUBERT — Nantes University Hospital
- Study coordinator: Elodie FAUREL-PAUL
- Email: Elodie.FAURELPAUL@chu-nantes.fr
- Phone: +33 (0) 2 44 76 81 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atopic Dermatitis, Eczema, Atopic