Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Thyroid Eye Disease
TED
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 monoc...
Eligibility Criteria
Inclusion
- \- Clinical diagnosis of TED based on CAS
Exclusion
- 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
Key Trial Info
Start Date :
October 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT05987423
Start Date
October 26 2023
End Date
July 1 2026
Last Update
November 4 2025
Active Locations (46)
Enter a location and click search to find clinical trials sorted by distance.
1
Thrive Health Research LLC
Beverly Hills, California, United States, 90210
2
UCSD Shiley Eye Center
La Jolla, California, United States, 92093-0946
3
Grene Vision Group, LLC
Wichita, Kansas, United States, 67206
4
Johns Hopkins University
Baltimore, Maryland, United States, 21205