Therapeutic Drug Monitoring of Tildrakizumab in Psoriasis Patients
NCT05683015 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-01-18
Summary
Biologics such as tildrakizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study, the investigators aim to investigate the predictive value of early serum trough levels of tildrakizumab and determine the therapeutic window of tildrakizumab in psoriasis patients.
Conditions
- Psoriasis Vulgaris
Interventions
- PROCEDURE
-
Venapuncture
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of tildrakizumab.
- PROCEDURE
-
Patient questionnaires
The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit.
Sponsors & Collaborators
-
University Hospital, Ghent
lead OTHER
Principal Investigators
-
Jo Lambert, Prof · University Ghent
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-22
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- Belgium
Study Locations
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