NCT06398106 Proactive TDM Versus Standard Use of Biologics in Psoriasis
| NCT ID | NCT06398106 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Ghent |
| Condition | Psoriasis Vulgaris |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 210 participants in total. It began in 2024-12-20 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.
Eligibility 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
Contact & Investigator
Jo Lambert, Prof.
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06398106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriasis Vulgaris. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06398106 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06398106 currently recruiting?
Yes, NCT06398106 is actively recruiting participants. Contact the research team at jo.lambert@uzgent.be for enrollment information.
Where is the NCT06398106 trial being conducted?
This trial is being conducted at Bruges, Belgium, Brussels, Belgium, Brussels, Belgium, Brussels, Belgium and 11 additional locations.
Who is sponsoring the NCT06398106 clinical trial?
NCT06398106 is sponsored by University Hospital, Ghent. The principal investigator is Jo Lambert, Prof. at University Hospital, Ghent. The trial plans to enroll 210 participants.
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