A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease (SatraGO-2)

May 13, 2026 updated by: Hoffmann-La Roche

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
    • Ontario
      • Toronto, Ontario, Canada, M3C 0G9
        • Toronto Retina Institute
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont
  • China
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, China, 100032
        • Peking Union Medical College Hospital
      • Beijing, China, 100730
        • Beijing Tongren Hospital, Capital Medical University
      • Xi'an, China, 710004
        • Xi'an Fourth Hospital
  • France
      • Nantes, France, 44093
        • CHU Nantes - Hotel Dieu
      • Paris, France, 75019
        • Fondation Rothschild
      • Paris, France, 75012
        • CHNO Hopital des Quinze Vingts
  • Israel
      • Jerusalem, Israel, 9112001
        • Hadassah MC
      • Petah Tikva, Israel, 4941492
        • Rabin MC
      • Ramat Gan, Israel
        • Sheba Medical Center
  • Poland
      • Bydgoszcz, Poland, 85-316
        • Specjalistyczny Osrodek Okulistyczny Oculomedica
      • Gdansk, Poland, 80-180
        • Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia
  • Portugal
      • Coimbra, Portugal, 3000-548
        • AIBILI - Association for Innovation and Biomedical Research on Light
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 003-722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 135-710
        • Samsung Medical Center
      • Seoul, South Korea, 06973
        • Chung-Ang University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d Hebron
      • Granada, Spain, 18012
        • Hospital Universitario Virgen de Las Nieves
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spain, 28031
        • Hospital Ramon y Cajal
      • Seville, Spain, 41007
        • Hospital Universitario Virgen De La Macarena
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe: Servicio de Oftalmologia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
        • Hospital Universitari de Bellvitge
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BF
        • Sussex Eye Hospital
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Gartnavel General Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Maidstone Hospital
  • United States
    • California
      • San Diego, California, United States, 92108
        • Plastics-Orbit-Neuro
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants, P.C.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Eye and Ear Infirmary
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8808
        • Vanderbilt Eye Institute
    • Texas
      • San Antonio, Texas, United States, 78251
        • Retina Consultants of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye
Time Frame: Baseline, Week 24
Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye.
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Absence of Motility-induced Pain
Time Frame: Week 24
Week 24
Percentage of Participants Achieving Absence of Spontaneous Pain
Time Frame: Week 24
Week 24
Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye
Time Frame: Week 48
Week 48
Percentage of Participants Requiring Surgical Intervention for TED
Time Frame: Up to Week 48
Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm
Time Frame: Baseline, Week 48 and from Week 24 to Week 48
Baseline, Week 48 and from Week 24 to Week 48
Serum Concentration of Satralizumab
Time Frame: Up to Week 24
Up to Week 24
Change in Proptosis
Time Frame: Baseline, Week 24, Week 48, and from Week 24 to Week 48
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
Time Frame: Baseline, Week 24, and Week 48
Baseline, Week 24, and Week 48
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)
Time Frame: Baseline, Week 24, Week 48 and from Week 24 to Week 48
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
Time Frame: Week 24, Week 48
Week 24, Week 48
Percentage of Participants Achieving a ≥ 2 Point Reduction in Clinical Activity Score (CAS) in the Study Eye
Time Frame: Baseline, Week 24, and Week 48
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, and Week 48
Percentage of Participants Achieving CAS Value of 0 or 1 in the Study eye
Time Frame: Week 24
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
Time Frame: Baseline, Week 24
The OSDI instrument is a validated dry eye questionnaire, designed to assess cornea and ocular surface symptoms. It comprises of 12 questions with three main sections concerning ocular symptoms, visual function, and environmental factors. For each 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 ranging from 0 to 100. Higher score indicates worse disease index.
Baseline, Week 24
Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores
Time Frame: Baseline, Week 24
The OSDI instrument is a validated dry eye questionnaire, designed to assess cornea and ocular surface symptoms. It comprises of 12 questions with three main sections concerning ocular symptoms, visual function, and environmental factors. For each 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 ranging from 0 to 100. Higher score indicates worse disease index.
Baseline, Week 24
Change in Oxford Corneal Staining Scores
Time Frame: Baseline, Week 24
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 disease index.
Baseline, Week 24
Change in CAS
Time Frame: Baseline, Week 48 and from Week 24 to Week 48
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)
Time Frame: Baseline up to Week 72
Baseline up to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

July 24, 2025

Study Completion (Estimated)

June 25, 2026

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP44729
  • 2023-503669-50-00 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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