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Идёт набор NCT07605845

Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia

Фаза I С лечением Immune Thrombocytopenia

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: GL-2045.
Кому может быть актуально
Состояния в реестре: Immune Thrombocytopenia. 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
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

Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia

Обзор

The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).

Подробное описание

This is a Phase 1b, open-label, multiple subcutaneous (SC) injection dose study in participants with ITP. The specific aims of this study are to determine:

* The safety of the study drug when given to participants with ITP * The effect of the study drug on safety blood tests and blood platelet counts * How the study drug affects certain responses in the body such as severity of bleeding, levels of fatigue and health-related quality of life * How much of the study drug gets into the bloodstream * The body's immune response to the study drug

This information, together with pharmacokinetic (PK) data, will help to establish doses and dosing regimens suitable for use in future studies. The effects of GL-2045 on multiple biomarkers will also be investigated.

Вмешательства

  • Препарат GL-2045
    Administrative route: SC injection

Первичные конечные точки

  • Incidence, severity and type of adverse events and laboratory abnormalities [Срок оценки: Screening (Days -28 to -2) to Follow-up (Day 55)]
  • Multiple measurements of change from baseline in platelet count [Срок оценки: Day -1 to Follow-up (Day 55)]
Вторичные конечные точки (9)
  • Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels [Срок оценки: Day 1 to Follow-up (Day 55)]
  • Change from Baseline in Classical Complement Pathway (CCP) Inhibition [Срок оценки: Day 1 to Follow-up (Day 55)]
  • Changes in bleeding scale [Срок оценки: Day -1 to Follow-up (Day 55)]
  • Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire [Срок оценки: Day -1 to Follow-up (Day 55)]
  • Changes from baseline in FACIT-Thrombocytopenia 6 Questionnaire [Срок оценки: Day -1 to Follow-up (Day 55)]
  • Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUCO-tlast) [Срок оценки: Day 1 to Follow-up (Day 55)]
  • Maximum observed concentration (Cmax) [Срок оценки: Day 1 to Follow-up (Day 55)]
  • Time of the maximum observed concentration (tmax) [Срок оценки: Day 1 to Follow-up (Day 55)]
  • Incidence of immune response to drug [Срок оценки: Day 1 to Day 48]

Критерии участия

Критерии включения

  • Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
  • Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
  • A platelet count of 10 to 49 × 10\^9/L at baseline.
  • Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility.
  • The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study.

Критерии исключения

  • Any serious adverse event (SAE) with prior IVIg dosing.
  • Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
  • Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
  • Abnormal organ function including liver and kidney.
  • Any previous or current treatments prohibited by the protocol.
  • Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®), eltrombopag (Revolade®), or avatrombopag (Doptelet®).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • Fortrea Clinical Research Unit Ltd — Leeds

Идентификаторы

NCT: NCT07605845 · GL-2045-03 · 2025-522629-36

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗