131 Participants Needed

Satralizumab for Thyroid Eye Disease

(SatraGO-1 Trial)

Recruiting at 71 trial locations
RS
Overseen ByReference Study ID Number GP44467 www.roche.com/about_roche/roche_worldwide.htm
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the idea that Satralizumab for Thyroid Eye Disease is an effective treatment?

The available research does not provide any data on the effectiveness of Satralizumab for treating Thyroid Eye Disease. Instead, the research focuses on other treatments like alemtuzumab and teprotumumab for this condition. Therefore, there is no evidence from the provided information to support the idea that Satralizumab is effective for Thyroid Eye Disease.12345

What safety data exists for Satralizumab in treating Thyroid Eye Disease?

The provided research does not contain safety data for Satralizumab (also known as Enspryng, SA-237, sapelizumab, satralizumab-mwge) in the treatment of Thyroid Eye Disease. The studies focus on Teprotumumab and Tocilizumab, which are different treatments for the same condition.14567

Is the drug Satralizumab a promising treatment for Thyroid Eye Disease?

There is no information available in the provided research articles about Satralizumab being a promising treatment for Thyroid Eye Disease. The articles focus on other treatments like Teprotumumab.248910

How does the drug Satralizumab differ from other treatments for thyroid eye disease?

Satralizumab is unique because it is primarily used for conditions like neuromyelitis optica spectrum disorder and works by targeting the interleukin-6 receptor, which is different from teprotumumab, the main drug for thyroid eye disease that targets the insulin-like growth factor 1 receptor (IGF-1R). This difference in mechanism of action may offer a novel approach to treating thyroid eye disease.248910

What is the purpose of this trial?

This trial is testing an injectable medicine called satralizumab for people with thyroid eye disease. The medicine works by blocking a protein that causes inflammation, which can help reduce swelling and discomfort in the eyes. The study aims to see how safe and effective this treatment is for these patients.

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for individuals with thyroid eye disease (TED) who have a stable condition without significant changes in symptoms or measurements recently. It's not for those needing urgent eye surgery, planning surgery during the study, pregnant or breastfeeding women, or anyone with other serious eye diseases that could affect results.

Inclusion Criteria

I have been diagnosed with thyroid eye disease.

Exclusion Criteria

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
My eye condition improved before the study started.
I don't need eye surgery or treatment during the study.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part I

Participants receive satralizumab or placebo every 4 weeks

24 weeks
6 visits (in-person)

Treatment Part II

Proptosis response-based individualized treatment

24 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Satralizumab
Trial Overview The trial is testing Satralizumab, an antibody targeting IL-6 receptors to treat TED. Participants will receive it subcutaneously and be compared to others receiving a placebo to measure effectiveness and safety.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SatralizumabExperimental Treatment1 Intervention
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
Group II: PlaceboPlacebo Group1 Intervention
In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study

Satralizumab is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

🇺🇸
Approved in United States as Enspryng for:
  • Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive
🇪🇺
Approved in European Union as Enspryng for:
  • Neuromyelitis optica spectrum disorder (NMOSD)
🇨🇦
Approved in Canada as Enspryng for:
  • Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive
🇯🇵
Approved in Japan as Enspryng for:
  • Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive
🇨🇭
Approved in Switzerland as Enspryng for:
  • Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

In a study of 18 patients with thyroid eye disease who did not respond to multiple steroid treatments, Tocilizumab significantly improved disease activity, as shown by a mean reduction of 5.89 points in the Clinical Activity Score (CAS).
Tocilizumab also led to a substantial decrease in thyroid-stimulating immunoglobulin (TSI) levels by 76.18% and improved symptoms such as proptosis and extraocular motility, with no severe side effects reported.
Treatment of active corticosteroid-resistant graves' orbitopathy.Pérez-Moreiras, JV., Alvarez-López, A., Gómez, EC.[2022]
Alemtuzumab-induced thyroid eye disease (AI-TED) can present with greater severity compared to conventional thyroid eye disease (TED), as indicated by an average clinical activity score of 3.3 among 16 patients studied, with some experiencing scores as high as 5.0 during active phases.
AI-TED may develop several months after the onset of Graves' disease, highlighting the need for healthcare providers to monitor patients for potential severe TED following treatment with alemtuzumab.
Alemtuzumab-Induced Thyroid Eye Disease: A Comprehensive Case Series and Review of the Literature.Nirmalan, A., Blecher, N., Hyder, S., et al.[2023]
In a study of 162 multiple sclerosis patients treated with alemtuzumab, 44% developed thyroid dysfunction, primarily Graves' disease, with 16% referred for thyroid eye disease (TED) evaluation.
Some patients experienced severe TED requiring systemic immunosuppression, highlighting the need for regular monitoring and early referral to ophthalmology, especially for those with elevated TSH-receptor antibody levels.
Immune reconstitution after alemtuzumab therapy for multiple sclerosis triggering Graves' orbitopathy: a case series.Roos, JCP., Moran, C., Chatterjee, VK., et al.[2022]

References

Treatment of active corticosteroid-resistant graves' orbitopathy. [2022]
Alemtuzumab-Induced Thyroid Eye Disease: A Comprehensive Case Series and Review of the Literature. [2023]
Immune reconstitution after alemtuzumab therapy for multiple sclerosis triggering Graves' orbitopathy: a case series. [2022]
Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment: OPTIC-X Study. [2022]
Frequency and Patterns of Hearing Dysfunction in Patients Treated with Teprotumumab. [2023]
Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease. [2023]
Teprotumumab-Related Adverse Events in Thyroid Eye Disease: A Multi-Center Study. [2023]
Teprotumumab for chronic thyroid eye disease. [2022]
Teprotumumab for the treatment of chronic thyroid eye disease. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy of teprotumumab therapy in patients with long-duration thyroid eye disease. [2023]
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