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

Study acronym: BIOLOPTIM-BRO
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv7
  3. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v6
  4. Primary completion date: Dec 31, 2022 to Dec 31, 2023v5
  5. Re-verified, no change to tracked fieldsv4
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  1. Lead sponsor: University Ghent to University Hospital, Ghent
    • Collaborators: 1 to 2
    v3
  2. Phase: Phase 4 to Not applicable
    • Secondary endpoints: details revised at 2 of 3 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04080635
Lead Sponsor University Hospital, Ghent
Collaborators: KU Leuven, University Ghent
Conditions
(from sponsor)		 Psoriasis Vulgaris
Related terms Psoriasis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov