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

October 6, 2025 updated by: Prof. Dr. Phyllis I. Spuls, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Recruiting
        • Amsterdam University Medical Centers
        • Contact:
          • Anouk Caron, MD
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Not yet recruiting
        • Erasmus Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean EASI
Time Frame: 24 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adapted iMCQ
Time Frame: 16 and 24 weeks
Adapted iMTA Medical Consumption Questionnaire
16 and 24 weeks
Adapted iPCQ
Time Frame: 16 and 24 weeks
Adapted iMTA Productivity Cost Questionnaire
16 and 24 weeks
Adapted iVICQ
Time Frame: 16 and 24 weeks
Adapted iMTA Valuation of Informal Care Questionnaire
16 and 24 weeks
Dupilumab serum trough levels
Time Frame: 0 and 24 weeks
Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms)
0 and 24 weeks
Adverse events
Time Frame: 16 and 24 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 and 24 weeks
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
Time Frame: 16 and 24 weeks
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
Time Frame: 16 and 24 weeks
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
Time Frame: 16 and 24 weeks
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
Time Frame: 16 and 24 weeks
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
Time Frame: 16 and 24 weeks
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
Time Frame: 16 and 24 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Erasmus Medical Center
Prothya Biosolutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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