DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.
Trial design
Design model
Parallel
Treatments tested in this trial
Dupilumab
DrugAdministering Dupilumab 300 mg at different dosing intervals.
Treatment groups
216 Participants
are divided into 3 treatment groupsGroup A: Dupilumab 300 mg q2wActive comparator 1 intervention
Group B: Dupilumab 300 mg q3wExperimental treatment 1 intervention
Group C: Dupilumab 300 mg q4wExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean EASI
The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.
Time frame
24 weeksSecondary outcomes
1
EASI
The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.
Time frame
16 weeks2
vIGA-AD
The mean Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). The vIGA-AD can range from 0 to 4, where a lower score indicates a better outcome.
Time frame
16 and 24 weeks3
PtGA
The mean patient self-reported Global Assessment of disease severity (PtGA). The PtGA can range from 0 to 4, where a lower score indicates a better outcome.
Time frame
16 and 24 weeks4
NRS
The mean Peak Pruritus Numerical Rating Scale (NRS). The NRS can range from 0 to 10, where a lower score indicates a better outcome.
Time frame
16 and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Erasmus Medical Center
Collaborator
Prothya Biosolutions
Collaborator
Source ClinicalTrials.gov