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

NCT05685940 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-05

No results posted yet for this 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.

Conditions

  • Psoriasis Vulgaris

Interventions

PROCEDURE

Venapuncture

Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of risankizumab.

PROCEDURE

Patient questionnaires

The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit.

Sponsors & Collaborators

  • 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
2020-04-05
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685940 on ClinicalTrials.gov