Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Led by University Hospital, Ghent · Updated on 2026-03-04

210

Participants Needed

15

Research Sites

166 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

B

Belgium Health Care Knowledge Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with psoriasis vulgaris by an accredited dermatologist
  • Currently treated with secukinumab, ixekizumab, or guselkumab for at least 6 months using standard dosing
  • Signed informed consent and any required privacy authorizations before study procedures
Not Eligible

You will not qualify if you...

  • Receiving biologics primarily for conditions other than plaque psoriasis (e.g., rheumatoid arthritis)
  • Using systemic immunosuppressants other than methotrexate or acitretin
  • Having severe comorbidities with short life expectancy or uncontrolled psoriatic arthritis at baseline
  • Unable to follow the study protocol
  • Actively wishing to become pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

AZ Sint-Jan

Bruges, Belgium

Actively Recruiting

2

CHU Saint-Pierre

Brussels, Belgium, 1000

Actively Recruiting

3

UCL Saint-Luc

Brussels, Belgium

Active, Not Recruiting

4

ULB Erasme

Brussels, Belgium

Not Yet Recruiting

5

UZ Brussel

Brussels, Belgium

Actively Recruiting

6

Grand Hôpital de Charleroi

Charleroi, Belgium

Active, Not Recruiting

7

AZ Alma

Eeklo, Belgium, 9900

Actively Recruiting

8

Dermatologiepraktijk huidziekten Geel

Geel, Belgium

Actively Recruiting

9

AZ Maria Middelares

Ghent, Belgium

Actively Recruiting

10

UZ Gent

Ghent, Belgium

Actively Recruiting

11

Clinique André Renard

Herstal, Belgium

Withdrawn

12

Dermatologie Handelskaai

Kortrijk, Belgium

Actively Recruiting

13

UZ Leuven

Leuven, Belgium

Actively Recruiting

14

CHU Liège

Liège, Belgium

Active, Not Recruiting

15

Dermatologie Maldegem

Maldegem, Belgium

Actively Recruiting

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Research Team

J

Jo Lambert, Prof

CONTACT

R

Rani Soenen, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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