DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema (DUPI REDUCE)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Enrolling; Phase 4

Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06004986

2023-504171-24-00

Details and patient eligibility

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.

Full description

While dupilumab is an effective treatment for atopic eczema, it is expensive and not without the risk of unwanted adverse events. Aiming for the lowest possible dose is important. The currently approved dose is a single loading dose of 600 mg, followed by 300 mg every 2 weeks. However, there is evidence that the intervals between doses could be extended in disease-controlled patients while maintaining the same effectiveness. The objective of this study is to assess the (cost)effectiveness and safety of dupilumab dose reduction in patients with controlled atopic eczema. A multicenter, single-blinded, non-inferiority randomized controlled trial will be performed, that is embedded in the TREatment of ATopic eczema (TREAT) NL registry. Adult patients who are already undergoing dupilumab treatment and meet the Treat-to-Target criteria will be assigned randomly to one of three groups: receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. The study will cover a duration of 24 weeks, during which participants will have three hospital visits (at week 0, week 16 and week 24) and one telephone appointment (at week 8). These sessions will involve assessments of both physician and patient-reported disease severity, quality of life and the evaluation of dupilumab serum trough levels. Please refer below for a comprehensive overview of the outcome measures.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 3 patient groups

Dupilumab 300 mg q2w

Active Comparator group

Description:

Dupilumab s.c. 300 mg every 2 weeks for 24 weeks.

Treatment:

Drug: Dupilumab

Dupilumab 300 mg q3w

Experimental group

Description:

Dupilumab s.c. 300 mg every 3 weeks for 24 weeks.

Treatment:

Drug: Dupilumab

Dupilumab 300 mg q4w

Experimental group

Description:

Dupilumab s.c. 300 mg every 4 weeks for 24 weeks.

Treatment:

Drug: Dupilumab