A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
NCT ID: NCT05987423
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
131 participants
INTERVENTIONAL
2023-10-26
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Satralizumab
In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study
Satralizumab
Satralizumab will be administered by SC injection.
Placebo
In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study
Placebo
Placebo will be administered by SC injection
Interventions
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Satralizumab
Satralizumab will be administered by SC injection.
Placebo
Placebo will be administered by SC injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Universitatsklinikum Munster
Münster, , Germany
Universitäts-Augenklinik Tübingen
Tübingen, , Germany
Hong Kong Eye Hospital
Mong Kok, , Hong Kong
Budapest Retina Associates Kft.
Budapest, , Hungary
A.O. U. Federico II
Napoli, Campania, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Aichi Medical University Hospital
Aichi, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Social Medical Corporation Tenjinkai Shinkoga Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Kobe Kaisei Hospital Medical foundation
Hyōgo, , Japan
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Olympia Eye Hospital
Tokyo, , Japan
National University Hospital
Singapore, , Singapore
Singapore Eye Research Institute
Singapore, , Singapore
Countries
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References
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Ezra D, Collins A, Haskova Z, Kuenzel T, Ida H, Triyatni M, Brittain C, Idowu O. Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. Ophthalmol Ther. 2025 Oct 9. doi: 10.1007/s40123-025-01255-3. Online ahead of print.
Other Identifiers
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2023-503309-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
GP44467
Identifier Type: -
Identifier Source: org_study_id
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