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Proactive TDM Versus Standard Use of Biologics in Psoriasis

RecruitingPhase 4Ages 18 Years - anyAllUniversity Hospital, Ghent
NCT06398106 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reac

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults; aged 18 years or older 2. Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist 3. Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme. 4. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures Exclusion Criteria: 1. Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication) 2. Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc) 3. Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline 4. Presumed inability to follow the study protocol 5. Active pregnancy wish
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What it tests

  • Proactive TDM-based dosing of secukinumab
  • Proactive TDM-based dosing of ixekizumab
  • Proactive TDM-based dosing of guselkumab
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Where

15 sites
AZ Sint-Jan
Bruges, Belgium
CHU Saint-Pierre
Brussels, Belgium
UCL Saint-Luc
Brussels, Belgium
ULB Erasme
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
AZ Alma
Eeklo, Belgium
Dermatologiepraktijk huidziekten Geel
Geel, Belgium

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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