NCT04080635

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
PROCEDURE	Venapuncture	Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab
OTHER	Patient questionnaires	The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L

Timeline

• Start date: 2018-12-14
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-09-06
• Last updated: 2024-09-19

Locations

7 sites across 1 country: Belgium