NCT06004986 DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
| NCT ID | NCT06004986 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2023-08-14 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 216 participants in total. It began in 2023-08-14 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Louise AA Gerbens, MD PhD
STUDY CHAIR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT06004986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06004986 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06004986 currently recruiting?
Yes, NCT06004986 is actively recruiting participants. Contact the research team at ph.i.spuls@amsterdamumc.nl for enrollment information.
Where is the NCT06004986 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT06004986 clinical trial?
NCT06004986 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Louise AA Gerbens, MD PhD at Amsterdam UMC, location VUmc. The trial plans to enroll 216 participants.
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