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

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.

Overview

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.

Interventions

• 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

Primary outcome measures

• Predictive value of early serum trough concentrations of brodalumab [Time frame: Week 0 until week 24 of treatment]
• Predictive value of early anti-drug antibodies of brodalumab [Time frame: Week 0 until week 24 of treatment]
• The development of a therapeutic window of brodalumab in psoriasis [Time frame: Week 0 until week 52 of treatment]

Secondary outcome measures (3)

• DLQI [Time frame: Week 0 until week 52 of treatment]
• EQ5D5L [Time frame: Week 0 until week 52 of treatment]
• EQ VAS [Time frame: Week 0 until week 52 of treatment]

Eligibility criteria

Inclusion criteria

• Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
• 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

• Participants who have currently a predominant nonplaque form of psoriasis
• Participants who are pregnant, nursing or planning a pregnancy
• Participants who are unable or unwilling to undergo multiple venapunctures
• Participants who are treated according to a different dosing schedule than standard dosing of brodalumab

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 7 centers

• AZ Maria Middelares — Ghent
• AZ Sint-Lucas — Ghent
• University Hospital of Ghent — Ghent
• Private Practice Dermatology — Maldegem
• University Hospital — Leuven
• AZ Sint-Jan — Bruges
• AZ Delta Rembert — Torhout

Identifiers

NCT: NCT04080635 · BC-03913 - BIOLOPTIM-BRO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗