2023-504171-24-00
Recruiting
Phase 4
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.
Amsterdam UMC3 sites in 1 country216 target enrollmentStarted: June 14, 2023Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Amsterdam UMC
- Enrollment
- 216
- Locations
- 3
- Primary Endpoint
- The mean Eczema Area and Severity Index (EASI) at week 16.
Overview
Brief Summary
To evaluate and compare the efficacy of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 16 weeks after randomization.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The subject is an adult.
- •The subject has a diagnosis of atopic eczema.
- •The subject receives dupilumab 300 mg every 2 weeks for the treatment of atopic eczema.
- •The subject has controlled disease according to the Treat-to-Target criteria.
- •The subject has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
Exclusion Criteria
- •The subject uses or initiates other systemic immunomodulating therapy for atopic eczema or another diagnosis.
Outcomes
Primary Outcomes
The mean Eczema Area and Severity Index (EASI) at week 16.
The mean Eczema Area and Severity Index (EASI) at week 16.
Secondary Outcomes
- EASI at week 24.
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
- Patient self-reported Global Assessment of disease severity (PtGA).
- Peak Pruritus Numerical Rating Scale (NRS).
- Patient-Oriented Eczema Measure (POEM).
- Dermatology Life Quality Index (DLQI).
- Recap of atopic eczema (RECAP).
- Dupilumab costs.
- EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers.
- Adapted iMCQ (iMTA Medical Consumption Questionnaire).
- Adapted iPCQ (iMTA Productivity Cost Questionnaire).
- Adapted iVICQ (iMTA Valuation of Informal Care Questionnaire).
- Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA).
- Percentage of dropouts and reasons.
- Dupilumab serum trough levels of 40 patients.
Investigators
Prof. Dr. Ph.I. Spuls
Scientific
Amsterdam UMC
Study Sites (3)
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