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NCT Number: NCT05987423

Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With 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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases TED Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Satralizumab

Drug

Satralizumab will be administered by SC injection.

Placebo

Drug

Placebo will be administered by SC injection

Primary outcomes

  1. Percentage of Participants Achieving ≥ 2mm 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 [≥ 2 millimeters (mm) increase] in the fellow eye

Secondary outcomes

  1. Change in Proptosis

    Time frame: Baseline, Week 24, Week 48 and from Week 24 to Week 48

  2. Percentage of Participants Achieving ≥ 1 Grade Reduction/Improvement in Diplopia Among Participants with Baseline Diplopia

    Time frame: Baseline, Week 24, Week 48

  3. Percentage of Participants Achieving Absence of Motility-induced Pain

    Time frame: Week 24

  4. Percentage of Participants Achieving Absence of Spontaneous Pain

    Time frame: Week 24

  5. 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.

  6. Percentage of Participants Achieving Overall Response

    Time frame: Week 24. Week 48

  7. Percentage of Participants Achieiving ≥2 Point Reduction in Clinical Activity Score (CAS) in the Study eye

    Time frame: Baseline, Week 24, 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.

  8. Percentage of Participants Acheiving 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.

  9. 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 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.

  10. 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 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.

  11. 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 worse disease index.

  12. Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye

    Time frame: Week 48

  13. Percentage of Participants Requiring Surgical Intervention for TED

    Time frame: Up to Week 48

  14. Percentage of Participants With Worsening of Proptosis by ≥ 2 mm

    Time frame: Baseline, Week 48 and from Week 24 to Week 48

  15. Change in CAS

    Time frame: Baseline, Week 48 and from Week 24 to 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.

  16. 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, Week 72

  17. Serum Concentration of Satralizumab

    Time frame: Up to Week 24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: SatraGO-1

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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