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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503309-13-00 | EU Trial (CTIS) Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Satralizumab | Experimental | 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 |
|
| Placebo | Placebo Comparator | In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Satralizumab | Drug | Satralizumab will be administered by SC injection. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
- Clinical diagnosis of TED based on CAS
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thrive Health Research LLC | Beverly Hills | California | 90210 | United States | ||
| UCSD Shiley Eye Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41066062 | Derived | 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. |
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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
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| Placebo |
| Drug |
Placebo will be administered by SC injection |
|
| 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 |
| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000655944 | satralizumab |
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