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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-05

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective, open label, non-randomized study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care - risankizumab

Patients will continue to receive risankizumab according to the standard dosing schedule: subcutaneous injections at weeks 0 and 4, then every 12 weeks (2x 75mg).

Group Type EXPERIMENTAL

Venapuncture

Intervention Type PROCEDURE

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

Patient questionnaires

Intervention Type PROCEDURE

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

Interventions

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Venapuncture

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

Intervention Type PROCEDURE

Patient questionnaires

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jo Lambert, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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