Optimizing biologic dosing for psoriasis treatment
Official title: Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study
Run by University Hospital, Ghent · NCT06398106 · Data updated 2026-11-12
This study is testing if a new way of adjusting psoriasis medication based on blood tests can work just as well as the usual method over 18 months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | secukinumab, ixekizumab, guselkumab, methotrexate, prednisone |
| Locations | 15 sites (Bruges and 14 other locations) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2028 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT06398106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a documented diagnosis of psoriasis vulgaris currently treated with secukinumab, ixekizumab, or guselkumab for at least six months.
✕Probably not a fit
Patients with other primary indications for biologic use or severe comorbidities may not benefit from this study.
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
Potential benefit: If successful, this approach could lead to more effective and personalized treatment for patients with psoriasis, reducing side effects and healthcare costs.
How similar studies have gone: Other studies have shown promise in using therapeutic drug monitoring for biologics, suggesting this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
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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
Show 9 more locations
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UZ Gent
Ghent, Belgium Recruiting -
Dermatologie Handelskaai
Kortrijk, Belgium Recruiting -
UZ Leuven
Leuven, Belgium Recruiting -
Dermatologie Maldegem
Maldegem, Belgium Recruiting -
UCL Saint-Luc
Brussels, Belgium Active not recruiting -
ULB Erasme
Brussels, Belgium Not yet recruiting -
Grand Hôpital de Charleroi
Charleroi, Belgium Active not recruiting -
Clinique André Renard
Herstal, Belgium Withdrawn -
CHU Liège
Liège, Belgium Active not 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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.