DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

NCT06004986 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2023-504171-24-00
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema

Keywords

Dupilumab

Outcome Measures

Primary Outcomes (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.

  24 weeks

Secondary Outcomes (13)

• EASI

  16 weeks

• vIGA-AD

  16 and 24 weeks

• PtGA

  16 and 24 weeks

• NRS

  16 and 24 weeks

• POEM

  16 and 24 weeks

Study Arms (3)

Dupilumab 300 mg q2w

ACTIVE COMPARATOR

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

Drug: Dupilumab

Dupilumab 300 mg q3w

EXPERIMENTAL

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

Drug: Dupilumab

Dupilumab 300 mg q4w

EXPERIMENTAL

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

Drug: Dupilumab

Interventions

Dupilumab DRUG

Administering Dupilumab 300 mg at different dosing intervals.

Also known as: Dupixent

Dupilumab 300 mg q2w; Dupilumab 300 mg q3w; Dupilumab 300 mg q4w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Erasmus Medical Center: collaborator
• Prothya Biosolutions: collaborator

Study Sites (2)

Amsterdam University Medical Centers

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Louise AA Gerbens, MD PhD

  Amsterdam University Medical Centers

  STUDY CHAIR

• Phyllis I Spuls, MD PhD

  Amsterdam University Medical Centers

  PRINCIPAL INVESTIGATOR

• DirkJan Hijnen, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phyllis I Spuls, MD PhD

CONTACT

+3120 566 9111; ph.i.spuls@amsterdamumc.nl

Anouk GM Caron, MD

CONTACT

+31653704573; a.caron@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. P.I. Spuls

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: August 14, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)