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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503669-50-00 | 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. |
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| 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 ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye | Provided there is no deterioration of proptosis (≥ 2mm 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, and 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 |
|---|---|---|---|---|---|---|
| Plastics-Orbit-Neuro | San Diego | California | 92108 | United States | ||
| Connecticut Eye Consultants, P.C. |
| 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 Achieving a ≥ 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, and Week 48 |
| Percentage of Participants Achieving 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, 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 | 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 | 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 |
| 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 | 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 up to Week 72 |
| Serum Concentration of Satralizumab | Up to Week 24 |
| 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 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 Clínico 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 |
| 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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