DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT06004986
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Administering Dupilumab 300 mg at different dosing intervals.

Study Details

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.

Key Dates

Start date
Aug 14, 2023
Status verified
Jan 2025
Primary completion
Oct 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Mean EASI [ Time Frame: 24 weeks ]

Central Contacts

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