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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (3)

• DLQI [Срок оценки: Week 0 until week 52 of treatment]
• EQ5D5L [Срок оценки: Week 0 until week 52 of treatment]
• EQ VAS [Срок оценки: Week 0 until week 52 of treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 7 центров

• 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

Идентификаторы

NCT: NCT04080635 · BC-03913 - BIOLOPTIM-BRO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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