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Идёт набор NCT06888193

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Фаза I С лечением Moderate to Severe Plaque Psoriasis Psoriatic Arthritis Axial Spondyloarthritis Hidradenitis Suppurativa

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bimekizumab.
Кому может быть актуально
Состояния в реестре: Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, Hidradenitis Suppurativa. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Канада, Германия, Испания, Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Обзор

Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.

Вмешательства

  • Препарат Bimekizumab
    Bimekizumab under the care of their treating physician.

Первичные конечные точки

  • Concentration of bimekizumab in the breast milk on Day 1 [Срок оценки: Day 1]
  • Concentration of bimekizumab in the breast milk on Day 2 [Срок оценки: Day 2]
  • Concentration of bimekizumab in the breast milk on Day 3 [Срок оценки: Day 3]
  • Concentration of bimekizumab in the breast milk on Day 5 [Срок оценки: Day 5]
  • Concentration of bimekizumab in the breast milk on Day 7 [Срок оценки: Day 7]
  • Concentration of bimekizumab in the breast milk on Day 9 [Срок оценки: Day 9]
  • Concentration of bimekizumab in the breast milk on Day 11 [Срок оценки: Day 11]
  • Concentration of bimekizumab in the breast milk on Day 13 [Срок оценки: Day 13]
  • Concentration of bimekizumab in the breast milk on Day 15 [Срок оценки: Day 15]
  • Concentration of bimekizumab in the breast milk on Day 29 [Срок оценки: Day 29]
Вторичные конечные точки (3)
  • Estimated Infant Dosage of bimekizumab from breast milk [Срок оценки: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57]
  • Relative Infant Dose of bimekizumab from breast milk [Срок оценки: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57]
  • Treatment-emergent Adverse Events (TEAEs) of the mother from time of informed consent through SFU contact [Срок оценки: From time of informed consent up to approximately 17 weeks]

Критерии участия

Критерии включения

  • Study participant must be at least 18 years of age at the time of signing the informed consent.
  • Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.
  • Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.
  • The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.
  • Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling (prior to start of the Sampling Period).
  • A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.

Критерии исключения

  • Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
  • The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.
  • Study participant has a history of chronic alcohol or drug abuse within the previous last year.
  • Study participant has history of breast implants, breast augmentation, or breast reduction surgery.
  • Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).
  • Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and/or an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.
  • Study participant or her infant has previously participated (ie, entered the sampling period) in this study.

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
Другое

Центры проведения

США · 6 центров
  • Up0122 105 — Santa Monica
  • Up0122 103 — South Miami
  • Up0122 104 — Boston
  • Up0122 106 — Chapel Hill
  • Up0122 102 — Durham
  • Up0122 101 — Milwaukee
Канада · 2 центра
  • Up0122 202 — Calgary
  • Up0122 201 — Vancouver
Германия · 2 центра
  • Up0122 301 — Freiburg im Breisgau
  • Up0122 303 — Herne
Испания · 2 центра
  • Up0122 501 — Barcelona
  • Up0122 502 — Barcelona
Швейцария · 2 центра
  • Up0122 602 — Lausanne
  • Up0122 601 — Sankt Gallen

Идентификаторы

NCT: NCT06888193 · UP0122 · 2024-518689-29 · U1111-1318-5063

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗