NCT04080635 Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
| NCT ID | NCT04080635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Psoriasis Vulgaris |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-12-14 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2018-12-14 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. 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: 1. Participants who have currently a predominant nonplaque form of psoriasis 2. Participants who are pregnant, nursing or planning a pregnancy 3. Participants who are unable or unwilling to undergo multiple venapunctures 4. Participants who are treated according to a different dosing schedule than standard dosing of brodalumab
Contact & Investigator
Jo Lambert, Prof.
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT04080635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriasis Vulgaris. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04080635 currently recruiting?
Yes, NCT04080635 is actively recruiting participants. Contact the research team at jo.lambert@uzgent.be for enrollment information.
Where is the NCT04080635 trial being conducted?
This trial is being conducted at Ghent, Belgium, Ghent, Belgium, Ghent, Belgium, Maldegem, Belgium and 3 additional locations.
Who is sponsoring the NCT04080635 clinical trial?
NCT04080635 is sponsored by University Hospital, Ghent. The principal investigator is Jo Lambert, Prof. at University Ghent. The trial plans to enroll 100 participants.
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