DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Atopic Dermatitis, Atopic Dermatitis Eczema

Intervention / Treatment
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* Drug: Dupilumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dupilumab 300 mg q2w<br>Dupilumab s.c. 300 mg every 2 weeks for 24 weeks. | Drug: Dupilumab<br>* Administering Dupilumab 300 mg at different dosing intervals.<br>* Other names: Dupixent;|
| Experimental: Dupilumab 300 mg q3w<br>Dupilumab s.c. 300 mg every 3 weeks for 24 weeks. | Drug: Dupilumab<br>* Administering Dupilumab 300 mg at different dosing intervals.<br>* Other names: Dupixent;|
| Experimental: Dupilumab 300 mg q4w<br>Dupilumab s.c. 300 mg every 4 weeks for 24 weeks. | Drug: Dupilumab<br>* Administering Dupilumab 300 mg at different dosing intervals.<br>* Other names: Dupixent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean EASI | The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI | The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome. | 16 weeks | 
| vIGA-AD | The mean Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). The vIGA-AD can range from 0 to 4, where a lower score indicates a better outcome. | 16 and 24 weeks | 
| PtGA | The mean patient self-reported Global Assessment of disease severity (PtGA). The PtGA can range from 0 to 4, where a lower score indicates a better outcome. | 16 and 24 weeks | 
| NRS | The mean Peak Pruritus Numerical Rating Scale (NRS). The NRS can range from 0 to 10, where a lower score indicates a better outcome. | 16 and 24 weeks | 
| POEM | The mean Patient-Oriented Eczema Measure (POEM). The POEM can range from 0 to 28, where a lower score indicates a better outcome. | 16 and 24 weeks | 
| DLQI | The mean Dermatology Life Quality Index (DLQI). The DLQI can range from 0 to 30, where a lower score indicates a better outcome. | 16 and 24 weeks | 
| RECAP | The mean Recap of atopic eczema (RECAP). The RECAP can range from 0 to 28, where a lower score indicates a better outcome. | 16 and 24 weeks | 
| EQ-5D-5L | The mean EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers. The EQ-5D-5L can range from 0 to 1, where a higher score indicates a better outcome. | 16 and 24 weeks | 
| Adapted iMCQ | Adapted iMTA Medical Consumption Questionnaire | 16 and 24 weeks | 
| Adapted iPCQ | Adapted iMTA Productivity Cost Questionnaire | 16 and 24 weeks | 
| Adapted iVICQ | Adapted iMTA Valuation of Informal Care Questionnaire | 16 and 24 weeks | 
| Dupilumab serum trough levels | Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms) | 0 and 24 weeks | 
| Adverse events | 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) | 16 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dupilumab