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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Thyroid Eye Disease; TED
• Intervention / Treatment: Drug: Satralizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425
    • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  • Capital Federal, Argentina, C1015ABO
    • Centro Oftalmologico Dr. Charles S.A.
  • Capital Federal, Argentina, C1120AAN
    • Oftalmos
  • Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
    • Buenos Aires Mácula
  • Mendoza, Argentina, M5500BWG
    • Centrovision Mendoza
  • Rosario, Argentina, S2000DLA
    • Grupo Laser Vision
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Sydney Eye Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Centre for Eye Research Australia
• Austria
  • Vienna, Austria, 1090
    • Medizinische Universität Wien
• Germany
  • Berlin, Germany, 13353
    • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Freiburg im Breisgau, Germany, 79106
    • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Tübingen, Germany, 72076
    • Universitäts-Augenklinik Tübingen
• Hong Kong
  • Mong Kok, Hong Kong
    • Hong Kong Eye Hospital
• Hungary
  • Budapest, Hungary, 1133
    • Budapest Retina Associates Kft.
• Italy
  • Campania
    • Naples, Campania, Italy, 80131
      • A.O. U. Federico II
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A Gemelli
  • Lombardy
    • Milan, Lombardy, Italy
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • Varese, Lombardy, Italy, 21100
      • Ospedale di Circolo e Fondazione Macchi
  • Tuscany
    • Pisa, Tuscany, Italy, 56124
      • Azienda Ospedaliero Universitaria Pisana
• Japan
  • Aichi, Japan, 480-1195
    • Aichi Medical University Hospital
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Fukuoka, Japan, 830-8577
    • Social Medical Corporation Tenjinkai Shinkoga Hospital
  • Hokkaido, Japan, 060-8648
    • Hokkaido University Hospital
  • Hyōgo, Japan, 657-0068
    • Kobe Kaisei Hospital Medical foundation
  • Kitakyushu-shi, Japan, 807-8556
    • Hospital of the University of Occupational and Environmental Health,Japan
  • Kyoto, Japan, 612-8555
    • National Hospital Organization Kyoto Medical Center
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Tokyo, Japan, 150-0001
    • Olympia Eye Hospital
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 168751
    • Singapore Eye Research Institute
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Thrive Health Research LLC
    • La Jolla, California, United States, 92093-0946
      • UCSD Shiley Eye Center
  • Kansas
    • Wichita, Kansas, United States, 67206
      • Grene Vision Group, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan, Kellogg Eye Center
    • Saint Joseph, Michigan, United States, 49085
      • Great Lakes Eye Care
  • New York
    • Great Neck, New York, United States, 11021
      • 'Northwell Health Physician Partners Ophthalmology
  • Oregon
    • Portland, Oregon, United States, 97225
      • EyeHealth Northwest
  • Texas
    • Austin, Texas, United States, 78705-1169
      • Austin Retina Associates
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Eyelid Center of Utah
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Clinical diagnosis of TED based on CAS

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Satralizumab; Satralizumab will be administered by SC injection.
Placebo Comparator: Placebo; In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study	Drug: Placebo; Placebo will be administered by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both the subscales and overall score are transformed to a scale of 0 to 100. Higher total scores indicate better QoL.	Baseline, Week 24, Week 48 and from Week 24 to Week 48
Percentage of Participants Achieving Overall Response		Week 24. Week 48
Percentage of Participants Achieiving ≥2 Point Reduction in Clinical Activity Score (CAS) in the Study eye	The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.	Baseline, Week 24, Week 48
Percentage of Participants Acheiving CAS Value of 0 or 1 in the Study eye	The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.	Week 24
Percentage of Participants Achieving ≥ 10 point Improvement in Ocular Surface Disease Index (OSDI) Overall Scores	The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors. It comprises of 12 questions and for every question, participants selects a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100. Higher scores represents a worse disease index.	Baseline, Week 24
Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores	The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors. It comprises of 12 questions and for every question, participants selects a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100. Higher scores represents a worse disease index.	Baseline, Week 24
Change in Oxford Corneal Staining Scores	Oxford corneal staining chart consists of a 6 point scale. Staining assessment will be based on the intensity of fluorescein staining, ranging from Grade 0 to V for each panel (Grade 0-I: normal; Grade II-III: mild to moderate; Grade IV-V: severe). Higher grade indicates worse worse disease index.	Baseline, Week 24
Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye		Week 48
Percentage of Participants Requiring Surgical Intervention for TED		Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm		Baseline, Week 48 and from Week 24 to Week 48
Change in CAS	The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.	Baseline, Week 48 and from Week 24 to Week 48
Percentage of Participants with Adverse Events (AEs), with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5)		Baseline, Week 72
Serum Concentration of Satralizumab		Up to Week 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): July 8, 2025
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy; satralizumab
• Other Study ID Numbers: GP44467; 2023-503309-13-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No