Optimizing biologic dosing for psoriasis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare proactive therapeutic drug monitoring (TDM) with standard dosing methods for biologics used in treating moderate to severe psoriasis. By measuring drug concentrations in patients' blood, the study seeks to adjust dosing intervals to achieve optimal drug levels, potentially improving treatment outcomes. The primary goal is to determine if proactive TDM is non-inferior to standard care in maintaining disease control over 18 months. Secondary objectives include evaluating quality of life, treatment satisfaction, and cost-effectiveness of the proactive approach.

Why it matters

Who can join: the full rules

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

Where it's running

• AZ Sint-Jan
  Bruges, Belgium Recruiting
• CHU Saint-Pierre
  Brussels, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• AZ Alma
  Eeklo, Belgium Recruiting
• Dermatologiepraktijk huidziekten Geel
  Geel, Belgium Recruiting
• AZ Maria Middelares
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Jo Lambert, Prof. — University Hospital, Ghent
• Study coordinator: Jo Lambert, Prof
• Email: jo.lambert@uzgent.be
• Phone: 093322298

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.