Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT04080635
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2019-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Brodalumab and the Development of Concentration-response Curve of Brodalumab of Psoriasis Patients.
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOLOPTIM-BRO
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.
Detailed Description:
Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of brodalumab (i.e. one loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards brodalumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: