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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective, open label, non-randomized study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care - brodalumab

Patients will continue to receive brodalumab according to standard care dosing regimen, i.e. loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks.

Group Type EXPERIMENTAL

Venapuncture

Intervention Type PROCEDURE

Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab

Patient questionnaires

Intervention Type OTHER

The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L

Interventions

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Venapuncture

Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab

Intervention Type PROCEDURE

Patient questionnaires

The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jo Lambert, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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