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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Thyroid Eye Disease

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

NCT06106828

Run by

Hoffmann-La Roche

People needed

127

Starts

2023-11-15

Expected to finish

2026-06-25

Last updated by the study team

2026-05-14

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

• Plastics-Orbit-Neuro — San Diego, California, United States
• Connecticut Eye Consultants, P.C. — Danbury, Connecticut, United States
• University of Illinois Eye and Ear Infirmary — Chicago, Illinois, United States
• Scheie Eye Institute — Philadelphia, Pennsylvania, United States
• Vanderbilt Eye Institute — Nashville, Tennessee, United States
• Retina Consultants of Texas — San Antonio, Texas, United States
• University of Alberta — Edmonton, Alberta, Canada
• Toronto Retina Institute — Toronto, Ontario, Canada
• Universite de Montreal - Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Peking Union Medical College Hospital — Beijing, China
• Peking University Third Hospital — Beijing, China
• Beijing Tongren Hospital, Capital Medical University — Beijing, China
• Xi'an Fourth Hospital — Xi'an, China
• CHU Nantes - Hotel Dieu — Nantes, France
• CHNO Hopital des Quinze Vingts — Paris, France
• Fondation Rothschild — Paris, France
• Hadassah MC — Jerusalem, Israel
• Rabin MC — Petah Tikva, Israel
• Sheba medical center — Ramat Gan, Israel
• Specjalistyczny Osrodek Okulistyczny Oculomedica — Bydgoszcz, Poland
• Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia — Gdansk, Poland
• AIBILI - Association for Innovation and Biomedical Research on Light — Coimbra, Portugal
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Chung-Ang University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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