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

Psoriasis Vulgaris Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685940
• Other study ID #: BIOLOPTIM-RIS
• Status: Recruiting
• Phase: Phase 4
• Start date: April 5, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Ghent
• Contact: Jo Lambert, Prof.
• Phone: 09 332 22 87
• Email: jo.lambert[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Procedure:
• Venapuncture
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of risankizumab.
• Patient questionnaires
The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit.

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge	West-Flanders
Belgium	AZ Maria Middelares	Ghent	East-Flanders
Belgium	AZ Sint-Lucas	Ghent	East-Flanders
Belgium	University Hospital Ghent	Ghent	East-Flanders
Belgium	University Hospital Leuven	Leuven	Vlaams-Brabant
Belgium	Private practice Dermatology	Maldegem	East-Flanders
Belgium	AZ Delta Rembert	Torhout	West-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of early serum trough concentrations of risankizumab	To assess the predictive value of early serum trough levels of risankizumab (µg/ml), the clinical response (PASI) at week 12 and/or week 24 will be correlated with serum trough concentrations of tildrakizumab measurements taken from week 0,1,2,3 and/or 4.	Week 0 until week 24 of treatment
Primary	Predictive value of early anti-drug antibodies of risankizumab	To assess the predictive value of early anti-drug antibodies of risankizumab (µg/ml), the clinical response (PASI) at week 12 and/or week 24 will be correlated with anti-drug antibodies of tildrakizumab measurements taken from week 0,1,2,3 and/or 4.	Week 0 until week 24 of treatment
Primary	Development of the therapeutic window of risankizumab in psoriasis	Defining a therapeutic window for risankizumab based on serum trough concentrations corresponding with adequate clinical response (ROC analysis and concentration-effect curve)	Week 0 until week 52 of treatment
Secondary	DLQI	The DLQI (Dermatology Life Quality Index) (range 0-30) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the disease on participant's QoL. It is a ten item questionnaire that, in addition to evaluated overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leasure, 4) work or school performances, 5) personal relationships, and 6) treatment.; The scoring of each question is as follows: Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.	Week 0 until week 52 of treatment
Secondary	EQ-5D-5L	The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits of the five dimensions can be combined into a 5- digit number that describes the patients' health state.	Week 0 until week 52 of treatment
Secondary	EQ VAS	The EQ VAS (Visual Analogue Scale) (range 0-10) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	Week 0 until week 52 of treatment