Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

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).

Official Title

A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease

Keywords

Thyroid Eye Disease, TED, Eye Diseases, Graves Ophthalmopathy, Thyroid Diseases, Satralizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Clinical diagnosis of TED based on CAS

You CAN'T join if...

  • 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

  • UCSD Shiley Eye Center accepting new patients
    La Jolla California 92093-0946 United States
  • Thrive Health Research LLC accepting new patients
    Beverly Hills California 90210 United States
  • USC Roski Eye Institute accepting new patients
    Los Angeles California 90333 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT05987423
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated