RECRUITINGINTERVENTIONAL

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Brodalumab and the Development of Concentration-response Curve of Brodalumab of Psoriasis Patients.

About This Trial

Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. 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 Who Should NOT Join This Trial: 1. Participants who have currently a predominant nonplaque form of psoriasis 2. Participants who are pregnant, nursing or planning a pregnancy 3. Participants who are unable or unwilling to undergo multiple venapunctures 4. Participants who are treated according to a different dosing schedule than standard dosing of brodalumab Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. 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: 1. Participants who have currently a predominant nonplaque form of psoriasis 2. Participants who are pregnant, nursing or planning a pregnancy 3. Participants who are unable or unwilling to undergo multiple venapunctures 4. Participants who are treated according to a different dosing schedule than standard dosing of brodalumab

Treatments Being Tested

PROCEDURE

Venapuncture

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

OTHER

Patient questionnaires

The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L

Locations (7)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, Belgium

University Hospital of Ghent

Ghent, Oost-Vlaanderen, Belgium

Private Practice Dermatology

Maldegem, Oost-Vlaanderen, Belgium

University Hospital

Leuven, Vlaams-Brabant, Belgium

AZ Sint-Jan

Bruges, West-Vlaanderen, Belgium

AZ Delta Rembert

Torhout, West-Vlaanderen, Belgium