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

Last updated: January 16, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Atopic Dermatitis

Dermatitis, Atopic

Rash

Treatment

Dupilumab step-down

Clinical Study ID

NCT05642208
RC22_0378
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 investigatorsince at least 6 months without tapering dosage of dupilumab

  • Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months andless than 60 g/month

Exclusion

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

Study Design

Total Participants: 256
Treatment Group(s): 1
Primary Treatment: Dupilumab step-down
Phase: 4
Study Start date:
March 08, 2023
Estimated Completion Date:
December 08, 2026

Study 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).

Connect with a study center

  • Amiens University hospital

    Amiens,
    France

    Site Not Available

  • CHU d'Angers

    Angers,
    France

    Active - Recruiting

  • Hôpital Victor Dupouy

    Argenteuil,
    France

    Terminated

  • CHU de Besançon

    Besançon,
    France

    Active - Recruiting

  • CHU de Bordeaux Adulte

    Bordeaux,
    France

    Active - Recruiting

  • CHRU de Brest

    Brest,
    France

    Active - Recruiting

  • CHU de Clermont Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon,
    France

    Active - Recruiting

  • CHU de Grenoble

    Grenoble,
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • GH La Rochelle - Ré-Aunis

    La Rochelle,
    France

    Active - Recruiting

  • CH de Le Mans

    Le Mans,
    France

    Active - Recruiting

  • CHRU de Lille

    Lille,
    France

    Active - Recruiting

  • Groupement des Hôpitaux de l'institut Catholique de Lille

    Lille,
    France

    Terminated

  • Hospices Civils de Lyon

    Lyon,
    France

    Active - Recruiting

  • Hôpital de la Timone

    Marseille,
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • CH de Niort

    Niort,
    France

    Active - Recruiting

  • Hôpital Cochin

    Paris,
    France

    Active - Recruiting

  • Hôpital Necker-Enfants malades

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint Louis

    Paris,
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris,
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers,
    France

    Active - Recruiting

  • CHU de Reims

    Reims,
    France

    Terminated

  • CHU de Rennes

    Rennes,
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen,
    France

    Active - Recruiting

  • CH de Saint Nazaire

    Saint-Nazaire,
    France

    Active - Recruiting

  • HIA Sainte Anne

    Toulon,
    France

    Active - Recruiting

  • CHU de Toulouse - Hôpital Larrey

    Toulouse,
    France

    Active - Recruiting

  • CHRU de Tours

    Tours,
    France

    Active - Recruiting

  • CHU de La Réunion

    Saint-Pierre, La Réunion
    Réunion

    Active - Recruiting

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