An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
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: XTMAB-16.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Sarcoidosis. Базовые параметры: 18 лет — 80 лет · Все.
- 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, Чехия, Польша, Великобритания
- 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 Long-term Multicenter Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement
Обзор
Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement
Подробное описание
A Long-term Multicenter Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement
Вмешательства
- Препарат XTMAB-16
XTMAB-16 infusion
Первичные конечные точки
- Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration [Срок оценки: Through study completion, an average of 4 years]
Вторичные конечные точки (8)
- Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing) [Срок оценки: Through study completion, an average of 4 years]
- Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung [Срок оценки: Through study completion, an average of 4 years]
- Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General [Срок оценки: Through study completion, an average of 4 years]
- Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire [Срок оценки: Through study completion, an average of 4 years]
- Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire [Срок оценки: Through study completion, an average of 4 years]
- Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity) [Срок оценки: Through study completion, an average of 4 years]
- Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing [Срок оценки: Through study completion, an average of 4 years]
- Long-term effect of XTAMB-16 on serum biomarkers important to cytokine pathway and granuloma formation (ACE, IL-6, sIL-2R, sTNFa, CRP, IL-1b, calcitriol) in sarcoidosis [Срок оценки: Through study completion, an average of 4 years]
Критерии участия
Критерии включения
Participants are eligible to be included in the study if the following criteria apply:
- Completion of XTMAB-16-201 study: completion of Week 12 (Part A) or Week 24 (Part B) assessments.
- Participants from XTMAB-16-201 Part A and Part B should be on a stable steroid dose for at least 2 weeks prior to informed consent/Day 1 of XTMAB-16-202 (Day 1 should occur at the next scheduled dosing visit on the assigned dose frequency cohort of XTMAB 16 201 ± 2 weeks).
Критерии исключения
Participants are excluded from the study if any of the following criteria apply:
- Evidence of treatment-related AEs requiring treatment discontinuation per XTMAB-16-201 protocol observed in XTMAB-16-201 study.
- Evidence of treatment failure observed in XTMAB-16-201 study per protocol definition.
- Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the 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
- Лечение
Центры проведения
США · 5 центров
- Xentria Investigative Site — Denver
- Xentria Investigative Site — Chicago
- Xentria Investigative Site — Greenville
- Xentria Investigative Site — Cincinnati
- Xentria Investigative Site — Philadelphia
Великобритания · 4 центра
- University Hospitals Coventry and Warwickshire NHS Trust — Coventry
- King's College Hospital NHS Foundation Trust — London
- Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich
- NHS Tayside — Perth
Чехия · 1 центр
- Xentria Investigative Site — Prague
Польша · 1 центр
- Xentria Investigative Site — Bielsk Podlaski
Идентификаторы
NCT: NCT06169397 · XTMAB-16-202