Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
Recruiting · NCT04080635 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Ghent
View the official record on ClinicalTrials.gov →Interventions studied
Patient questionnairesVenapuncture
What this trial is about
Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
- Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion criteria
- Participants who have currently a predominant nonplaque form of psoriasis
- Participants who are pregnant, nursing or planning a pregnancy
- Participants who are unable or unwilling to undergo multiple venapunctures
- Participants who are treated according to a different dosing schedule than standard dosing of brodalumab
Where it is running
7 locations listed.
- AZ Maria Middelares - Ghent, Oost-Vlaanderen, Belgium
- AZ Sint-Lucas - Ghent, Oost-Vlaanderen, Belgium
- University Hospital of Ghent - Ghent, Oost-Vlaanderen, Belgium
- Private Practice Dermatology - Maldegem, Oost-Vlaanderen, Belgium
- University Hospital - Leuven, Vlaams-Brabant, Belgium
- AZ Sint-Jan - Bruges, West-Vlaanderen, Belgium
- AZ Delta Rembert - Torhout, West-Vlaanderen, Belgium