NCT05685940

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

4.7 years

First QC Date

December 21, 2022

Last Update Submit

February 2, 2024

Conditions

Psoriasis Vulgaris

Keywords

Therapeutic drug monitoringPsoriasisRisankizumab

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • DLQI

    Week 0 until week 52 of treatment

  • EQ-5D-5L

    Week 0 until week 52 of treatment

  • EQ VAS

    Week 0 until week 52 of treatment

Study Arms (1)

Standard of care - risankizumab

EXPERIMENTAL

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).

Procedure: VenapunctureProcedure: Patient questionnaires

Interventions

VenapuncturePROCEDURE

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

Standard of care - risankizumab
Patient questionnairesPROCEDURE

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

Standard of care - risankizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

NOT YET RECRUITING

AZ Sint-Lucas

Ghent, East-Flanders, 9000, Belgium

NOT YET RECRUITING

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Private practice Dermatology

Maldegem, East-Flanders, 9990, Belgium

NOT YET RECRUITING

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

AZ Sint-Jan

Bruges, West-Flanders, 8000, Belgium

NOT YET RECRUITING

AZ Delta Rembert

Torhout, West-Flanders, 8820, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jo Lambert, Prof.

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo Lambert, Prof.

CONTACT

09 332 22 87jo.lambert@uzgent.be

Rani Soenen, Dr.

CONTACT

09 332 22 87rani.soenen@uzgent.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective, open label, non-randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 17, 2023

Study Start

April 5, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(7)