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Search / Trial NCT05642208

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

Launched by NANTES UNIVERSITY HOSPITAL · Dec 7, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage atopic dermatitis (AD), which is a type of eczema, in adolescents and adults who have been stable on dupilumab treatment for at least six months. Researchers want to see if giving dupilumab injections less frequently can maintain the control of AD just as well as the usual treatment schedule. The study will look at how well patients do over time by measuring their skin condition using specific assessments.

To be eligible for this trial, participants need to be at least 12 years old and have been receiving dupilumab injections every two weeks for at least a year. They should have moderate to severe AD that has been well-controlled for six months, meaning their symptoms are low and stable. Participants will be required to provide consent, and those who qualify will have the opportunity to take part in this important research. It’s a chance to help improve treatment strategies for atopic dermatitis while potentially benefiting from a different dosing approach.

Gender

ALL

Eligibility 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

Trial Officials

Hélène AUBERT

Principal Investigator

Nantes University Hospital

About Nantes University Hospital

Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.

Locations

Paris, , France

Grenoble, , France

Paris, , France

Nantes, , France

Rouen, , France

Lille, , France

Paris, , France

Poitiers, , France

Angers, , France

Lyon, , France

Rennes, , France

Rouen, , France

Reims, , France

Dijon, , France

Brest, , France

Tours, , France

Marseille, , France

Montpellier, , France

Niort, , France

Reims, , France

Amiens, , France

Paris, , France

Besançon, , France

Toulon, , France

Lille, , France

Toulouse, , France

La Roche Sur Yon, , France

Clermont Ferrand, , France

Saint Nazaire, , France

Argenteuil, , France

Bordeaux, , France

Le Mans, , France

Saint Pierre, La Réunion, Réunion

La Rochelle, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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