Status:
ACTIVE_NOT_RECRUITING
Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Belgium Health Care Knowledge Centre
Conditions:
Psoriasis
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main objective of this study is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care in psoriasis patients. Therefore, a pra...
Detailed Description
Rationale: Biologics are very effective treatments for psoriasis. Research indicated that the dose of TNFα-blocking biologics can be reduced in a proportion of patients. Safety profiles can improve an...
Eligibility Criteria
Inclusion
- Plaque psoriasis (primarily)
- Treatment for at least 6 months with IL23 or IL17 inhibitor in a normal dose (dose advised by the label)
- PASI≤ 5 at inclusion and in previous 6 months (if no PASI scores are available, it should be clear from the patient record that psoriasis was clear/almost clear in previous 6 months).
- DLQI ≤ 5 at inclusion
Exclusion
- Another indication than plaque psoriasis as the main indication for biologic use (e.g. patient receives biologic for rheumatoid arthritis as the main indication).
- Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc).
- Severe comorbidities with short life-expectancy (e.g. metastasized tumor).
- Presumed inability to follow the study protocol.
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04340076
Start Date
August 20 2020
End Date
December 1 2025
Last Update
September 11 2025
Active Locations (19)
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1
ULB Erasme
Brussels, Belgium
2
Ghent University Hospital
Ghent, Belgium, 9000
3
AZ Maria Middelares
Ghent, Belgium
4
AZ St Lucas
Ghent, Belgium