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Atopic DermatitisPhase 4DUPI REDUCENCT06004986

DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

A Phase 4 study testing Dupilumab in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis, Atopic Dermatitis Eczema
What is being tested?
Dupilumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
2 sitesNetherlands
Study dates
14 Aug 2023to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Amsterdam University Medical Centers

    Amsterdam, North Holland, 1105 AZ

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Dupilumab
Keywords
Dupilumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called Dupixent

    Administering Dupilumab 300 mg at different dosing intervals.

Study groups in NCT06004986
Study groupRoleWhat they receive
Dupilumab 300 mg q2wActive comparatorDupilumab s.c. 300 mg every 2 weeks for 24 weeks.
Receives: Drug: Dupilumab
Dupilumab 300 mg q3wExperimentalDupilumab s.c. 300 mg every 3 weeks for 24 weeks.
Receives: Drug: Dupilumab
Dupilumab 300 mg q4wExperimentalDupilumab s.c. 300 mg every 4 weeks for 24 weeks.
Receives: Drug: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 weeks

Secondary outcomes (13)

  1. 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.

    Measured: 16 weeks

  2. 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.

    Measured: 16 and 24 weeks

  3. 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.

    Measured: 16 and 24 weeks

  4. 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.

    Measured: 16 and 24 weeks

  5. POEM

    The mean Patient-Oriented Eczema Measure (POEM). The POEM can range from 0 to 28, where a lower score indicates a better outcome.

    Measured: 16 and 24 weeks

  6. DLQI

    The mean Dermatology Life Quality Index (DLQI). The DLQI can range from 0 to 30, where a lower score indicates a better outcome.

    Measured: 16 and 24 weeks

  7. RECAP

    The mean Recap of atopic eczema (RECAP). The RECAP can range from 0 to 28, where a lower score indicates a better outcome.

    Measured: 16 and 24 weeks

  8. 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.

    Measured: 16 and 24 weeks

  9. Adapted iMCQ

    Adapted iMTA Medical Consumption Questionnaire

    Measured: 16 and 24 weeks

  10. Adapted iPCQ

    Adapted iMTA Productivity Cost Questionnaire

    Measured: 16 and 24 weeks

  11. Adapted iVICQ

    Adapted iMTA Valuation of Informal Care Questionnaire

    Measured: 16 and 24 weeks

  12. Dupilumab serum trough levels

    Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms)

    Measured: 0 and 24 weeks

  13. 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)

    Measured: 16 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start14 Aug 2023
  3. Primary completion5 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004986
Sponsor's protocol ID
2023-504171-24-00
Other IDs
2023
Acronym
DUPI REDUCE
Status last verified
Oct 2026
First submitted
15 Aug 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dupilumab in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean EASI (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06004986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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