DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

NCT ID: NCT06004986

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2025-12-31

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.

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dupilumab 300 mg q2w

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

Group Type: ACTIVE_COMPARATOR

Dupilumab

Intervention Type: DRUG

Administering Dupilumab 300 mg at different dosing intervals.

Dupilumab 300 mg q3w

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

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Administering Dupilumab 300 mg at different dosing intervals.

Dupilumab 300 mg q4w

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

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Administering Dupilumab 300 mg at different dosing intervals.

Interventions

Dupilumab

Administering Dupilumab 300 mg at different dosing intervals.

Intervention Type: DRUG

Other Intervention Names

Dupixent

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Prothya Biosolutions

INDUSTRY

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Phyllis I. Spuls

Prof. Dr. P.I. Spuls

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise AA Gerbens, MD PhD

Role: STUDY_CHAIR

Amsterdam University Medical Centers

Phyllis I Spuls, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Centers

DirkJan Hijnen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Amsterdam University Medical Centers

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status: NOT_YET_RECRUITING

Countries

Netherlands

Central Contacts

Phyllis I Spuls, MD PhD

Role: CONTACT

ph.i.spuls@amsterdamumc.nl

+3120 566 9111

Anouk GM Caron, MD

Role: CONTACT

a.caron@amsterdamumc.nl

+31653704573

Facility Contacts

Anouk Caron, MD

Role: primary

DirkJan Hijnen, MD PhD

Role: primary

d.hijnen@erasmusmc.nl

+3110 704 0704

Other Identifiers

2023-504171-24-00

Identifier Type: -

Identifier Source: org_study_id