Clinical trial NCT05685940: Therapeutic Drug Monitoring of Risankizumab in Psoriasis Patients (BIOLOPTIM-RIS)
Official title: Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Risankizumab and the Development of a Response-concentration Curve for Risankizumab in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Keywords: Therapeutic drug monitoring
Psoriasis
Risankizumab
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, open label, non-randomized study
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Predictive value of early serum trough concentrations of risankizumab
timeFrame: Week 0 until week 24 of treatment
measure: Predictive value of early anti-drug antibodies of risankizumab
timeFrame: Week 0 until week 24 of treatment
measure: Development of the therapeutic window of risankizumab in psoriasis
timeFrame: Week 0 until week 52 of treatment
Secondary outcomes:
measure: DLQI
timeFrame: Week 0 until week 52 of treatment
measure: EQ-5D-5L
timeFrame: Week 0 until week 52 of treatment
measure: EQ VAS
timeFrame: Week 0 until week 52 of treatment
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
state: East-Flanders
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
state: East-Flanders
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East-Flanders
city: Maldegem
country: Belgium
facility: Private practice Dermatology
state: East-Flanders
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan
state: West-Flanders
city: Torhout
country: Belgium
facility: AZ Delta Rembert
state: West-Flanders
Study officials:
affiliation: University Ghent
name: Jo Lambert, Prof.
role: PRINCIPAL_INVESTIGATOR
References: