Atopic Dermatitis Clinical Trials

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DUPI REDUCE Trial (DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema): a Multicenter, Low-intervention, Non-inferiority Randomized Controlled Trial, Embedded in the TREAT NL Registry

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam University Medical Centers
RECRUITING
Amsterdam
Erasmus Medical Center
NOT_YET_RECRUITING
Rotterdam
Contact Information
Primary
Phyllis I Spuls, MD PhD
ph.i.spuls@amsterdamumc.nl
+3120 566 9111
Backup
Anouk GM Caron, MD
a.caron@amsterdamumc.nl
+31653704573
Time Frame
Start Date: 2023-08-14
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 216
Treatments
Active_comparator: Dupilumab 300 mg q2w
Dupilumab s.c. 300 mg every 2 weeks for 24 weeks.
Experimental: Dupilumab 300 mg q3w
Dupilumab s.c. 300 mg every 3 weeks for 24 weeks.
Experimental: Dupilumab 300 mg q4w
Dupilumab s.c. 300 mg every 4 weeks for 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Erasmus Medical Center, Prothya Biosolutions

This content was sourced from clinicaltrials.gov