Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
Recruiting now · Not applicable
Conditions studied: Psoriasis Vulgaris
In brief
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.
Key facts
- Study ID
- NCT04080635
- Run by
- University Hospital, Ghent
- People needed
- 100
- Starts
- 2018-12-14
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- University Hospital of Ghent — Ghent, Oost-Vlaanderen, Belgium (enrolling)
- University Hospital — Leuven, Vlaams-Brabant, Belgium
- AZ Sint-Jan — Bruges, West-Vlaanderen, Belgium
- Private Practice Dermatology — Maldegem, Oost-Vlaanderen, Belgium
- AZ Maria Middelares — Ghent, Oost-Vlaanderen, Belgium
- AZ Sint-Lucas — Ghent, Oost-Vlaanderen, Belgium
- AZ Delta Rembert — Torhout, West-Vlaanderen, Belgium
Full record on ClinicalTrials.gov
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