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Активно (без набиране) Фаза 3 NCT05987423

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

Фаза 3 – широко изпитване преди одобрение
Заболявания: Thyroid Eye Disease TED

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).
Кой може да участва
Inclusion Criteria: \- Clinical diagnosis of TED based on CAS Exclusion Criteria: * Decrease in CAS or proptosis of \>= 2 points or \>= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1) * Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator * Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab
Места на провеждане 9
Argentina (1)
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires
Австралия (1)
Sydney Eye Hospital
Sydney , New South Wales
Германия (1)
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin
Hong Kong (1)
Hong Kong Eye Hospital
Mong Kok
Унгария (1)
Budapest Retina Associates Kft.
Budapest
Италия (1)
A.O. U. Federico II
Naples , Campania
Япония (1)
Aichi Medical University Hospital
Aichi
Сингапур (1)
National University Hospital
Singapore
САЩ (1)
Thrive Health Research LLC
Beverly Hills , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
26.10.2023
Крайна дата
01.07.2026
Регистрационен номер
NCT05987423
Източник
anzctr
Запитване за медицински туризъм

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