A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
SatraGO-2
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
127
10 countries
41
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 Nov 2023
Typical duration for phase_3
41 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
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2026
CompletedResults Posted
Study results publicly available
August 12, 2026
CompletedAugust 12, 2026
July 1, 2026
1.7 years
October 25, 2023
July 20, 2026
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye have been reported. Percentages have been rounded off.
At Week 24
Secondary Outcomes (40)
Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
At Week 24
Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye
At Week 24
Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
At Week 24
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
At Week 24
Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
At Week 24
- +35 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 (41)
Plastics-Orbit-Neuro
San Diego, California, 92108, United States
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, 06810, United States
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232-8808, United States
Retina Consultants of Texas
San Antonio, Texas, 78251, United States
University of Alberta
Edmonton, Alberta, Canada
Toronto Retina Institute
Toronto, Ontario, M3C 0G9, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Peking Union Medical College Hospital
Beijing, 100032, China
Peking University Third Hospital
Beijing, 100191, China
Beijing Hospital of Ministry of Health
Beijing, 100730, China
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730, China
Xi'an Fourth Hospital
Xi'an, 710004, China
CHU Nantes - Hotel Dieu
Nantes, 44093, France
CHNO Hopital des Quinze Vingts
Paris, 75012, France
Fondation Rothschild
Paris, 75019, France
Hadassah MC
Jerusalem, 9112001, Israel
Rabin MC
Petah Tikva, 4941492, Israel
Sheba medical center
Ramat Gan, Israel
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, 85-316, Poland
Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
Gdansk, 80-180, Poland
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, 3000-548, Portugal
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 003-722, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Hospital Universitario Vall d Hebron
Barcelona, 08035, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18012, Spain
Hospital Ramon y Cajal
Madrid, 28031, Spain
Hospital Universitario ClĂnico San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41007, Spain
Hospital Universitario la Fe: Servicio de Oftalmologia
Valencia, 46026, Spain
Sussex Eye Hospital
Brighton, BN2 5BF, United Kingdom
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
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)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
October 25, 2023
First Posted
October 30, 2023
Study Start
November 15, 2023
Primary Completion
July 24, 2025
Study Completion
June 25, 2026
Last Updated
August 12, 2026
Results First Posted
August 12, 2026
Record last verified: 2026-07
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