Clinical trial NCT06004986: DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Atopic Dermatitis Eczema
Keywords: Dupilumab
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Prothya Biosolutions
First posted: 2023-08-22
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean EASI
timeFrame: 24 weeks
Secondary outcomes:
measure: EASI
timeFrame: 16 weeks
measure: vIGA-AD
timeFrame: 16 and 24 weeks
measure: PtGA
timeFrame: 16 and 24 weeks
measure: NRS
timeFrame: 16 and 24 weeks
measure: POEM
timeFrame: 16 and 24 weeks
measure: DLQI
timeFrame: 16 and 24 weeks
measure: RECAP
timeFrame: 16 and 24 weeks
measure: EQ-5D-5L
timeFrame: 16 and 24 weeks
measure: Adapted iMCQ
timeFrame: 16 and 24 weeks
measure: Adapted iPCQ
timeFrame: 16 and 24 weeks
measure: Adapted iVICQ
timeFrame: 16 and 24 weeks
measure: Dupilumab serum trough levels
timeFrame: 0 and 24 weeks
measure: Adverse events
timeFrame: 16 and 24 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Amsterdam University Medical Centers
name: Louise AA Gerbens, MD PhD
role: STUDY_CHAIR
affiliation: Amsterdam University Medical Centers
name: Phyllis I Spuls, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: DirkJan Hijnen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: