Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients

NCT04080648 | Completed Phase 4

• 1 other identifier: BC-3118 - BIOLOPTIM-GUS
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 7

Brief Summary

Biologic such as guselkumab 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 we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.

Conditions

Psoriasis Vulgaris

Keywords

Therapeutic drug monitoring; Psoriasis; Guselkumab

Outcome Measures

Primary Outcomes (3)

• Predictive value of early serum trough concentrations of guselkumab

  Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations of guselkumab 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 guselkumab

  Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.

  Week 0 until week 24 of treatment

• Development of the therapeutic window of guselkumab in psoriasis

  Defining a therapeutic window for guselkumab based on serum trough concentrations corresponding with adequate clinical response

  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 case - guselkumab

OTHER

Patients will continue to receive guselkumab according to the standard dosing schedule; subcutaneous injection of 100 mg at weeks 0 and 4 and then every 8 weeks

Procedure: Venapuncture; Other: Patient questionnaires

Interventions

Venapuncture PROCEDURE

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

Standard of case - guselkumab

Patient questionnaires OTHER

The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit

Standard of case - guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 guselkumab

Sponsors & Collaborators

• University Hospital, Ghent: lead
• KU Leuven: collaborator
• University Ghent: collaborator

Study Sites (7)

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

Location

AZ Sint-Lucas

Ghent, East-Flanders, 9000, Belgium

Location

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Private practice Dermatology

Maldegem, East-Flanders, 9990, Belgium

Location

University Hospital

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Sint-Jan

Bruges, West-Flanders, 8000, Belgium

Location

AZ Delta Rembert

Torhout, West-Flanders, 8820, Belgium

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jo Lambert, Prof.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, open label, non-randomized study

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: September 6, 2019
• Study Start: June 27, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (7)