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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema
• Intervention / Treatment: Drug: Dupilumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Phyllis I Spuls, MD PhD; Phone Number: +3120 566 9111; Email: ph.i.spuls@amsterdamumc.nl
• Study Contact Backup: Name: Anouk GM Caron, MD; Phone Number: +31653704573; Email: a.caron@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • Amsterdam University Medical Centers
      • Contact: Anouk Caron, MD
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Not yet recruiting
      • Erasmus Medical Center
      • Contact: DirkJan Hijnen, MD PhD; Phone Number: +3110 704 0704; Email: d.hijnen@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Erasmus Medical Center; Prothya Biosolutions
• Investigators: Study Chair: Louise AA Gerbens, MD PhD, Amsterdam University Medical Centers; Principal Investigator: Phyllis I Spuls, MD PhD, Amsterdam University Medical Centers; Principal Investigator: DirkJan Hijnen, MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dupilumab
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 2023-504171-24-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes