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Active (not recruiting) Phase 3 NCT05987423

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

Phase 3 – large-scale trial before approval
Conditions: Thyroid Eye Disease TED

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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).
Who can participate
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
Locations 9
Argentina (1)
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires
Australia (1)
Sydney Eye Hospital
Sydney , New South Wales
Germany (1)
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin
Hong Kong (1)
Hong Kong Eye Hospital
Mong Kok
Hungary (1)
Budapest Retina Associates Kft.
Budapest
Italy (1)
A.O. U. Federico II
Naples , Campania
Japan (1)
Aichi Medical University Hospital
Aichi
Singapore (1)
National University Hospital
Singapore
United States (1)
Thrive Health Research LLC
Beverly Hills , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
26.10.2023
Completion date
01.07.2026
Registry ID
NCT05987423
Source
anzctr
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