Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients
NCT04083612 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2024-09-19
Summary
Biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab 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 ixekizumab
- OTHER
-
Patient questionnaires
The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L questionnaires at each study visit.
Sponsors & Collaborators
-
KU Leuven
collaborator OTHER -
University Ghent
collaborator OTHER -
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
- 2020-05-04
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Belgium
Study Locations
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