Меню
Набор скоро начнётся NCT07612267

A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

Фаза IV С лечением Lactation Inflammatory Bowel Disease

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: Mirikizumab.
Кому может быть актуально
Состояния в реестре: Lactation, Inflammatory Bowel Disease. Базовые параметры: от 3 Weeks · 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, Дания, Германия, Израиль +3
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

Обзор

The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication. Participation in this study could last up to 94 days, including screening and follow-up period.

Вмешательства

  • Препарат Mirikizumab
    Administered SC

Первичные конечные точки

  • Concentration of Mirikizumab in Breast Milk [Срок оценки: Predose up to 28 Days]
Вторичные конечные точки (3)
  • Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk [Срок оценки: Predose up to 28 Days]
  • Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve Over a Dosing Interval [AUC(0-tau)] of Mirikizumab in Breast Milk [Срок оценки: Predose up to 28 Days]
  • Breastfed Infant Safety as Assessed through Measurement of Infant Weight [Срок оценки: Predose up to 28 Days]

Критерии участия

Критерии включения

Study Participants:

  • Mothers who are at minimum 18 years of age and their infants who are at least 36 weeks gestation age at birth and at least 3 weeks old by Study Day 0
  • Multiple births may be allowed following discussion with the medical monitor.

Note: in the opinion of the healthcare practitioner (HCP), there are no infant or maternal issues that would preclude the mother participant or the infant from participation

  • Lactation history is well established, with the mother exclusively breastfeeding her infant
  • Mother participant is receiving mirikizumab therapeutically for an approved diagnosis (having received at least 2 doses of mirikizumab SC maintenance therapy every 4 weeks prior to study Day 0)
  • Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula

Критерии исключения

  • Have a history of inadequate lactation, for multiparous participants who have previously breastfed
  • Have a significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking mirikizumab, or of interfering with the interpretation of data
  • Have any condition that fulfills any contraindication stated in the label. All warnings and precautions stated in the label need to be considered
  • Have a history of breast augmentation procedures judged to have a clinical impact on breast milk expression such as breast reduction surgery and some breast implants, or current evidence of acute or chronic conditions affecting breasts and potentially interfering with breast milk collection
  • Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before enrollment or intend to receive a live vaccine during the study or an inactivated vaccine 2 weeks postdose, the mother participant must be given the vaccine at an injection site remote from mirikizumab administration

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 · 5 центров
  • Northwest Gastroenterologist — Glenview
  • University of Iowa — Iowa City
  • Johns Hopkins Bayview Medical Center — Baltimore
  • Digestive Disease Medicine of Central New York — Utica
  • University Hospitals Cleveland Medical Center — Cleveland
Израиль · 4 центра
  • Rabin Medical Center - PPDS — HaMerkaz
  • Shaare Zedek Medical Center — Jerusalem
  • Chaim Sheba Medical Center — Ramat Gan
  • Tel Aviv Sourasky Medical Center Ichilov - PPDS — Tel Aviv
Италия · 4 центра
  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS — Lazio
  • Ospedale San Raffaele S.r.l. - PPDS — Lombardia
  • Ospedale di Rho - UOC Gastroenterologia — Rho
  • Ospedale Sandro Pertini — Roma
Дания · 3 центра
  • Aarhus Universitetshospital, Aarhus Sygehus — Aarhus N
  • Rigshospitalet — Copenhagen
  • Slagelse Hospital — Slagelse
Германия · 2 центра
  • Interdisziplinäres Crohn Colitis Centrum Rhein-Main — Frankfurt am Main
  • Klinikum Ernst von Bergmann — Potsdam
Польша · 2 центра
  • DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6 — Radom
  • WIP Warsaw IBD Point Profesor Kierkus — Warsaw
Канада · 1 центр
  • GI Research — Columbia
Испания · 1 центр
  • Hospital Universitario La Paz — Madrid

Идентификаторы

NCT: NCT07612267 · 18780 · I6T-MC-AMCA · 2025-522362-78-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗