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
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 :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT06106828
Start Date
November 15 2023
End Date
July 1 2026
Last Update
November 17 2025
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Plastics-Orbit-Neuro
San Diego, California, United States, 92108
2
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, United States, 06810
3
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, United States, 60612
4
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104