Overview

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
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 pragmatic, multicentre, randomized, controlled, non-inferiority study will be carried out.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radboud University
Collaborators:
Belgium Health Care Knowledge Centre
University Hospital, Ghent
ZonMw: The Netherlands Organisation for Health Research and Development
Treatments:
Brodalumab
Ixekizumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.