Status:
RECRUITING
DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Erasmus Medical Center
Prothya Biosolutions
Conditions:
Atopic Dermatitis
Atopic Dermatitis Eczema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this randomized controlled trial is to study the (cost)effectiveness of extending the intervals between dupilumab doses in patients with well-controlled atopic eczema, while considering ph...
Detailed Description
While dupilumab is an effective treatment for atopic eczema, it is expensive and not without the risk of unwanted adverse events. Aiming for the lowest possible dose is important. The currently approv...
Eligibility Criteria
Inclusion
- The subject is an adult,
- Has a diagnosis of AE,
- Receives dupilumab 300 mg q2w for the treatment of AE,
- Has controlled disease according to the Treat-to-Target criteria,
- Agrees to the possibility that the dosage of dupilumab will be lowered,
- Has voluntarily signed and dated an informed consent prior to any study related procedure.
Exclusion
- The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06004986
Start Date
August 14 2023
End Date
December 31 2025
Last Update
October 8 2025
Active Locations (2)
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1
Amsterdam University Medical Centers
Amsterdam, North Holland, Netherlands, 1105 AZ
2
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD