DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Recruiting · NCT06004986 · Interventional (participants receive a specific treatment) · Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 physician- and patient-reported disease severity, quality of life, and dupilumab serum trough levels. Patients will be divided randomly into three groups, receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. Researchers will then compare the outcomes among these three groups.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.
Where it is running
2 locations listed.
- Amsterdam University Medical Centers - Amsterdam, North Holland, Netherlands
- Erasmus Medical Center - Rotterdam, South Holland, Netherlands