RecruitingNot ApplicableNCT04080635

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.


Sponsor

University Hospital, Ghent

Enrollment

100 participants

Start Date

Dec 14, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how well therapeutic drug monitoring — measuring the level of the medication brodalumab in a patient's bloodstream — can predict treatment outcomes in people with chronic plaque psoriasis. Brodalumab is a biologic injection used to treat moderate-to-severe psoriasis, and like all biologics, different people break it down at different rates. Some people may have too little in their system (so it doesn't work) while others may have more than needed. This study aims to understand the relationship between drug levels and treatment response. By understanding optimal drug concentrations, doctors may be able to personalise treatment — increasing the dose for poor responders before switching medications, or reducing frequency for those with very high levels. This research is part of a broader movement towards precision medicine in dermatology. You may be eligible if: - You have a confirmed clinical or histological (biopsy) diagnosis of chronic plaque psoriasis - You are currently being treated with brodalumab at a standard dosing schedule - You are willing and able to sign an informed consent form You may NOT be eligible if: - Your predominant psoriasis type is not plaque psoriasis (e.g., pustular, erythrodermic) - You are pregnant, breastfeeding, or planning a pregnancy - You are unable or unwilling to have multiple blood draws - You are on a non-standard brodalumab dosing schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVenapuncture

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

OTHERPatient 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

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NCT04080635


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