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

Completed · Phase 3 · Has a placebo group

Conditions studied: Thyroid Eye Disease, TED

In brief

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).

Key facts

Study ID

NCT05987423

Run by

Hoffmann-La Roche

People needed

131

Starts

2023-10-26

Expected to finish

2026-06-25

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of TED based on CAS

You may not qualify 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

Where it is running

• Thrive Health Research LLC — Beverly Hills, California, United States
• UCSD Shiley Eye Center — La Jolla, California, United States
• Grene Vision Group, LLC — Wichita, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan, Kellogg Eye Center — Ann Arbor, Michigan, United States
• Great Lakes Eye Care — Saint Joseph, Michigan, United States
• 'Northwell Health Physician Partners Ophthalmology — Great Neck, New York, United States
• EyeHealth Northwest — Portland, Oregon, United States
• Austin Retina Associates — Austin, Texas, United States
• Eyelid Center of Utah — Salt Lake City, Utah, United States
• WVU Eye Institute — Morgantown, West Virginia, United States
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires, Argentina
• Centro Oftalmologico Dr. Charles S.A. — Capital Federal, Argentina
• Oftalmos — Capital Federal, Argentina
• Buenos Aires Mácula — Ciudad Autonoma Buenos Aires, Argentina
• Centrovision Mendoza — Mendoza, Argentina
• Grupo Laser Vision — Rosario, Argentina
• Sydney Eye Hospital — Sydney, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Centre For Eye Research Australia — East Melbourne, Victoria, Australia
• Medizinische Universitat Wien — Vienna, Austria
• Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum — Berlin, Germany
• Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde — Dresden, Germany
• Universitätsklinikum Essen — Essen, Germany
• Universitätsklinikum Freiburg, Klinik für Augenheilkunde — Freiburg im Breisgau, Germany

Full record on ClinicalTrials.gov

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