Last updated 3 months ago
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease
120 patients around the world
Available in Argentina, United States
Hoffmann-La Roche
2Research sites
120Patients around the world
This study is for people with
Thyroid Disease
Thyroid Eye Disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Clinical diagnosis of thyroid eye disease (TED) based on CAS.
- 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 12 weeks after the final dose of satralizumab.
Sites
Instituto Oftalmológico de Buenos Aires / Oftalmos
Recruiting
Buenos Aires Mácula S.A.
Recruiting
SponsorHoffmann-La Roche
Conditions
Thyroid Eye Disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05987423
