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

Save

Report Abuse

Description

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.

Targeted Conditions

Study Overview

Start Date
April 5, 2020
Completion Date
December 31, 2024
Enrollment
100
Date Posted
January 17, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
University Hospital Ghent
Ghent, East-Flanders 9000, Belgium

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
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 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 standard dosing of risankizumab

Study Contact Info

Study Contact Name
Jo Lambert, Prof.; Rani Soenen, Dr.
Study Contact Phone

Contact Listings Owner Form

Therapeutic Drug Monitoring of Risankizumab in Psoriasis Patients (BIOLOPTIM-RIS) 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed 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.
NCTid (if applicable)
NCT05685940