Therapeutic Drug Monitoring of Risankizumab in Psoriasis Patients (BIOLOPTIM-RIS)

Last updated: February 2, 2024
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

4

Condition

Scalp Disorders

Warts

Psoriasis And Psoriatic Disorders

Treatment

Patient questionnaires

Venapuncture

Clinical Study ID

NCT05685940
BIOLOPTIM-RIS
  • Ages > 18
  • All Genders

Study Summary

Biologics such as risankizumab 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 risankizumab and determine the therapeutic window of risankizumab 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 risankizumab

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Patient questionnaires
Phase: 4
Study Start date:
April 05, 2020
Estimated Completion Date:
December 31, 2024

Study Description

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of risankizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (2x 75mg)). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards risankizumab. 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

  • AZ Maria Middelares

    Ghent, East-Flanders 9000
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Ghent, East-Flanders 9000
    Belgium

    Site Not Available

  • University Hospital Ghent

    Ghent, East-Flanders 9000
    Belgium

    Active - Recruiting

  • Private practice Dermatology

    Maldegem, East-Flanders 9990
    Belgium

    Site Not Available

  • University Hospital Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • AZ Sint-Jan

    Brugge, West-Flanders 8000
    Belgium

    Site Not Available

  • AZ Delta Rembert

    Torhout, West-Flanders 8820
    Belgium

    Site Not Available

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