Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
SatraGO-1
A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease
2 other identifiers
interventional
131
9 countries
43
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 monoclonal antibody, in participants with thyroid eye disease (TED).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2023
Typical duration for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2026
ExpectedMay 5, 2026
April 1, 2026
1.7 years
July 5, 2023
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis from Baseline (Day 1) at Week 24 in the Study eye
Provided there is no deterioration of proptosis \[≥ 2 millimeters (mm) increase\] in the fellow eye
Baseline, Week 24
Secondary Outcomes (17)
Change in Proptosis
Baseline, Week 24, Week 48 and from Week 24 to Week 48
Percentage of Participants Achieving ≥ 1 Grade Reduction/Improvement in Diplopia Among Participants with Baseline Diplopia
Baseline, Week 24, Week 48
Percentage of Participants Achieving Absence of Motility-induced Pain
Week 24
Percentage of Participants Achieving Absence of Spontaneous Pain
Week 24
Percentage of Participants with a ≥ 6 Point Improvement in the Visual Functioning and Appearance Sub-Scale Scores of the Graves Ophthalmopathy Quality of Life (GO-QoL)
Baseline, Week 24, Week 48 and from Week 24 to Week 48
- +12 more secondary outcomes
Study Arms (2)
Satralizumab
EXPERIMENTALIn 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
Placebo
PLACEBO COMPARATORIn the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Thrive Health Research LLC
Beverly Hills, California, 90210, United States
UCSD Shiley Eye Center
La Jolla, California, 92093-0946, United States
Grene Vision Group, LLC
Wichita, Kansas, 67206, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Great Lakes Eye Care
Saint Joseph, Michigan, 49085, United States
'Northwell Health Physician Partners Ophthalmology
Great Neck, New York, 11021, United States
EyeHealth Northwest
Portland, Oregon, 97225, United States
Austin Retina Associates
Austin, Texas, 78705-1169, United States
Eyelid Center of Utah
Salt Lake City, Utah, 84102, United States
WVU Eye Institute
Morgantown, West Virginia, 26506, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425, Argentina
Centro Oftalmologico Dr. Charles S.A.
Capital Federal, C1015ABO, Argentina
Oftalmos
Capital Federal, C1120AAN, Argentina
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, C1061AAE, Argentina
Centrovision Mendoza
Mendoza, M5500BWG, Argentina
Grupo Laser Vision
Rosario, S2000DLA, Argentina
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Medizinische Universitat Wien
Vienna, 1090, Austria
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, 13353, Germany
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Dresden, 01307, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Universitäts-Augenklinik Tübingen
Tübingen, 72076, Germany
Hong Kong Eye Hospital
Mong Kok, Hong Kong
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
A.O. U. Federico II
Naples, Campania, 80131, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese, Lombardy, 21100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56124, Italy
Aichi Medical University Hospital
Aichi, 480-1195, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Social Medical Corporation Tenjinkai Shinkoga Hospital
Fukuoka, 830-8577, Japan
Hokkaido University Hospital
Hokkaido, 060-8648, Japan
Kobe Kaisei Hospital Medical foundation
Hyōgo, 657-0068, Japan
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, 807-8556, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Olympia Eye Hospital
Tokyo, 150-0001, Japan
National University Hospital
Singapore, 119074, Singapore
Singapore Eye Research Institute
Singapore, 168751, Singapore
Related Publications (1)
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 Dec;14(12):3119-3132. doi: 10.1007/s40123-025-01255-3. Epub 2025 Oct 9.
PMID: 41066062DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2023
First Posted
August 14, 2023
Study Start
October 26, 2023
Primary Completion
July 8, 2025
Study Completion (Estimated)
June 5, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing