NCT05683015

Therapeutic Drug Monitoring of Tildrakizumab in Psoriasis Patients

Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Tildrakizumab and the Development of a Concentration Response Curve of Tildrakizumab for Psoriasis Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of tildrakizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (100mg)). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards tildrakizumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-22
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-01-12
• Last updated: 2024-01-18

Locations

2 sites across 1 country: Belgium