Optimizing biologic dosing for psoriasis treatment
Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study
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 |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | secukinumab, ixekizumab, guselkumab, methotrexate, prednisone |
| Locations | 15 sites (Bruges and 14 other locations) |
| Trial ID | NCT06398106 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other primary indications for biologic use or severe comorbidities may not benefit from this study.
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 performed: Other studies have shown promise in using therapeutic drug monitoring for biologics, suggesting this approach may be beneficial.
Eligibility criteria
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 this trial is running
Bruges and 14 other locations
- AZ Sint-Jan — Bruges, Belgium (Recruiting)
- CHU Saint-Pierre — Brussels, Belgium (Recruiting)
- UCL Saint-Luc — Brussels, Belgium (Active_not_recruiting)
- ULB Erasme — Brussels, Belgium (Not_yet_recruiting)
- UZ Brussel — Brussels, Belgium (Recruiting)
- Grand Hôpital de Charleroi — Charleroi, Belgium (Active_not_recruiting)
- AZ Alma — Eeklo, Belgium (Recruiting)
- Dermatologiepraktijk huidziekten Geel — Geel, Belgium (Recruiting)
- AZ Maria Middelares — Ghent, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Recruiting)
- Clinique André Renard — Herstal, Belgium (Withdrawn)
- Dermatologie Handelskaai — Kortrijk, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU Liège — Liège, Belgium (Active_not_recruiting)
- Dermatologie Maldegem — Maldegem, Belgium (Recruiting)
Study contacts
- Principal investigator: Jo Lambert, Prof. — University Hospital, Ghent
- Study coordinator: Jo Lambert, Prof
- Email: jo.lambert@uzgent.be
- Phone: 093322298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.