Reducing dupilumab doses for patients with controlled atopic eczema
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
This study is testing if giving dupilumab injections less often can still help people with well-controlled atopic eczema feel good while saving money and reducing side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | dupilumab |
| Locations | 2 sites (Amsterdam, North Holland and 1 other locations) |
| Trial ID | NCT06004986 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness and safety of extending the intervals between dupilumab doses in patients with well-controlled atopic eczema. Participants will be randomly assigned to receive dupilumab 300 mg every 2, 3, or 4 weeks. The study will assess physician- and patient-reported disease severity, quality of life, and dupilumab serum trough levels over a 24-week period. The goal is to determine if a lower dosing frequency can maintain treatment efficacy while reducing costs and potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults with a diagnosis of atopic eczema who are currently receiving dupilumab and have controlled disease.
Not a fit: Patients who are not currently on dupilumab or those with uncontrolled atopic eczema may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lower treatment costs and minimize adverse effects for patients with atopic eczema.
How similar studies have performed: Previous studies have suggested that extending dosing intervals for biologic therapies can be effective, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amsterdam, North Holland and 1 other locations
- Amsterdam University Medical Centers — Amsterdam, North Holland, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Phyllis I Spuls, MD PhD — Amsterdam UMC, location VUmc
- Study coordinator: Phyllis I Spuls, MD PhD
- Email: ph.i.spuls@amsterdamumc.nl
- Phone: +3120 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.