RecruitingPhase 4NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study


Sponsor

University Hospital, Ghent

Enrollment

210 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Proactive TDM-based dosing of guselkumab, a drug called Proactive TDM-based dosing of ixekizumab, and others for people with psoriasis vulgaris. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProactive TDM-based dosing of secukinumab

Maintenance/normal dose is 300 mg/4 weeks or 300 mg/ month First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks. Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 300 mg/3 weeks Second dose escalation step: 300 mg/2 weeks Further dose escalation step: shortening with 1 additional week

DRUGProactive TDM-based dosing of ixekizumab

Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 80 mg/3 weeks Second dose escalation step: 80 mg/2 weeks Further dose escalation step: shortening with 1 additional week

DRUGProactive TDM-based dosing of guselkumab

Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks. Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 100 mg/6 weeks Second dose escalation step: 100 mg/4 weeks Further dose escalation step: shortening with 1 additional week


Locations(15)

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

AZ Maria Middelares

Ghent, Belgium

UZ Gent

Ghent, Belgium

Clinique André Renard

Herstal, Belgium

Dermatologie Handelskaai

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

CHU Liège

Liège, Belgium

Dermatologie Maldegem

Maldegem, Belgium

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NCT06398106


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