Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Last updated: September 5, 2024
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psoriasis And Psoriatic Disorders

Warts

Rash

Treatment

Venapuncture

Patient questionnaires

Clinical Study ID

NCT04080635
BC-03913 - BIOLOPTIM-BRO
  • Ages > 18
  • All Genders

Study Summary

Biologics, such as brodalumab, 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 we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must have a clinical or histological diagnosis of chronic plaque-typepsoriasis

  2. 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:

  1. Participants who have currently a predominant nonplaque form of psoriasis

  2. Participants who are pregnant, nursing or planning a pregnancy

  3. Participants who are unable or unwilling to undergo multiple venapunctures

  4. Participants who are treated according to a different dosing schedule than standarddosing of brodalumab

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Venapuncture
Phase:
Study Start date:
December 14, 2018
Estimated Completion Date:
December 31, 2024

Study Description

Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of brodalumab (i.e. one loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards brodalumab. In addition, the Psoriasis Severity and Area Index (PASI) and the 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, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Ghent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • University Hospital of Ghent

    Ghent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Private Practice Dermatology

    Maldegem, Oost-Vlaanderen 9990
    Belgium

    Site Not Available

  • University Hospital

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • AZ Sint-Jan

    Bruges, West-Vlaanderen 8000
    Belgium

    Site Not Available

  • AZ Delta Rembert

    Torhout, West-Vlaanderen 8820
    Belgium

    Site Not Available

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