Therapeutic Drug Monitoring of Tildrakizumab in Psoriasis Patients

Last updated: January 17, 2024
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

4

Condition

Warts

Rosacea

Rash

Treatment

Venapuncture

Patient questionnaires

Clinical Study ID

NCT05683015
BIOLOPTIM-TIL
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a clinical or histological diagnosis of chronic plaque-typepsoriasis
  • Participants must sign an ICF indicating that he or she understands the purpose of,and procedures required for, the study and is willing to participate in the study

Exclusion

Exclusion Criteria:

  • Participants who have currently a predominant nonplaque form of psoriasis
  • Participants who are pregnant, nursing or planning a pregnancy
  • Participants who are unable or unwilling to undergo multiple venapunctures
  • Participants who are treated according to a different dosing schedule than standarddosing of tildrakizumab

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Venapuncture
Phase: 4
Study Start date:
August 22, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University Hospital Ghent

    Ghent, 9000
    Belgium

    Active - Recruiting

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