Actively Recruiting
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
Eligibility Criteria
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
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
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
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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