Идёт набор NCT06112340

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Фаза II / Фаза III С лечением Thyroid Eye Disease Graves Orbitopathy Endocrine System Diseases Eye Diseases

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: linsitinib.
Кому может быть актуально: Состояния в реестре: Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases, Eye Diseases. Базовые параметры: от 18 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
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, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Обзор

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

Вмешательства

Препарат linsitinib
Study medication taken twice daily by mouth

Первичные конечные точки

Percentage of Subjects who are Proptosis Responders at Week 24 [Срок оценки: 24 weeks]

Вторичные конечные точки (4)

Change from Baseline in Proptosis to Week 24 (Study Eye) [Срок оценки: 24 weeks]
Percentage of Subjects who are Overall Responders at Week 24 [Срок оценки: 24 weeks]
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye) [Срок оценки: 24 weeks]
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24 [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (< 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301
Subject has not received any treatment for TED since Week 24 of VGN-TED-301
Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \[FT4\] and free triiodothyronine levels \[FT3\] <50% above or below the normal limits) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial
Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study