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

Primary Purpose

Atopic Dermatitis, Atopic Dermatitis Eczema

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Dupilumab
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Dupilumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Amsterdam University Medical CentersRecruiting
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Dupilumab 300 mg q2w

Dupilumab 300 mg q3w

Dupilumab 300 mg q4w

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
POEM
The mean Patient-Oriented Eczema Measure (POEM). The POEM can range from 0 to 28, where a lower score indicates a better outcome.
DLQI
The mean Dermatology Life Quality Index (DLQI). The DLQI can range from 0 to 30, where a lower score indicates a better outcome.
RECAP
The mean Recap of atopic eczema (RECAP). The RECAP can range from 0 to 28, where a lower score indicates a better outcome.
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.
Adapted iMCQ
Adapted iMTA Medical Consumption Questionnaire
Adapted iPCQ
Adapted iMTA Productivity Cost Questionnaire
Adapted iVICQ
Adapted iMTA Valuation of Informal Care Questionnaire
Dupilumab serum trough levels
Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms)
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)

Full Information

First Posted
August 15, 2023
Last Updated
August 30, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Erasmus Medical Center, Prothya Biosolutions
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1. Study Identification

Unique Protocol Identification Number
NCT06004986
Brief Title
DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Acronym
DUPI REDUCE
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Erasmus Medical Center, Prothya Biosolutions

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Atopic Dermatitis Eczema
Keywords
Dupilumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab 300 mg q2w
Arm Type
Active Comparator
Arm Description
Dupilumab s.c. 300 mg every 2 weeks for 24 weeks.
Arm Title
Dupilumab 300 mg q3w
Arm Type
Experimental
Arm Description
Dupilumab s.c. 300 mg every 3 weeks for 24 weeks.
Arm Title
Dupilumab 300 mg q4w
Arm Type
Experimental
Arm Description
Dupilumab s.c. 300 mg every 4 weeks for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
Dupixent
Intervention Description
Administering Dupilumab 300 mg at different dosing intervals.
Primary Outcome Measure Information:
Title
Mean EASI
Description
The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
EASI
Description
The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.
Time Frame
16 weeks
Title
vIGA-AD
Description
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.
Time Frame
16 and 24 weeks
Title
PtGA
Description
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.
Time Frame
16 and 24 weeks
Title
NRS
Description
The mean Peak Pruritus Numerical Rating Scale (NRS). The NRS can range from 0 to 10, where a lower score indicates a better outcome.
Time Frame
16 and 24 weeks
Title
POEM
Description
The mean Patient-Oriented Eczema Measure (POEM). The POEM can range from 0 to 28, where a lower score indicates a better outcome.
Time Frame
16 and 24 weeks
Title
DLQI
Description
The mean Dermatology Life Quality Index (DLQI). The DLQI can range from 0 to 30, where a lower score indicates a better outcome.
Time Frame
16 and 24 weeks
Title
RECAP
Description
The mean Recap of atopic eczema (RECAP). The RECAP can range from 0 to 28, where a lower score indicates a better outcome.
Time Frame
16 and 24 weeks
Title
EQ-5D-5L
Description
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.
Time Frame
16 and 24 weeks
Title
Adapted iMCQ
Description
Adapted iMTA Medical Consumption Questionnaire
Time Frame
16 and 24 weeks
Title
Adapted iPCQ
Description
Adapted iMTA Productivity Cost Questionnaire
Time Frame
16 and 24 weeks
Title
Adapted iVICQ
Description
Adapted iMTA Valuation of Informal Care Questionnaire
Time Frame
16 and 24 weeks
Title
Dupilumab serum trough levels
Description
Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms)
Time Frame
0 and 24 weeks
Title
Adverse events
Description
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)
Time Frame
16 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phyllis I Spuls, MD PhD
Phone
+3120 566 9111
Email
ph.i.spuls@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Anouk GM Caron, MD
Phone
+31653704573
Email
a.caron@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise AA Gerbens, MD PhD
Organizational Affiliation
Amsterdam University Medical Centers
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Phyllis I Spuls, MD PhD
Organizational Affiliation
Amsterdam University Medical Centers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DirkJan Hijnen, MD PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam University Medical Centers
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anouk Caron, MD
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DirkJan Hijnen, MD PhD
Phone
+3110 704 0704
Email
d.hijnen@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

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