What is the mechanism of action of this treatment?

Graves' Ophthalmopathy (GO) is an autoimmune inflammatory disorder affecting the orbit around the eye, often associated with thyroid disease. Treatments targeting the immune system are crucial for managing GO. Satralizumab, an anti-IL-6 receptor monoclonal antibody, works by inhibiting the IL-6 pathway, which plays a significant role in the inflammatory process of GO. By blocking IL-6, Satralizumab reduces inflammation and immune response, potentially alleviating symptoms. Similarly, Rituximab, an anti-CD20 monoclonal antibody, depletes B-cells, which are involved in the autoimmune response, thereby reducing inflammation and tissue damage. Corticosteroids, another common treatment, suppress the overall immune response and inflammation. These treatments are essential for GO patients as they target the underlying autoimmune mechanisms, providing relief from symptoms and preventing disease progression.

What side effects are associated with this type of intervention?

Common treatments for Graves' Ophthalmopathy include glucocorticoids, which can cause side effects such as weight gain, mood swings, and increased risk of infections. Rituximab, another monoclonal antibody, may lead to infusion reactions, infections, and low blood cell counts. Treatments similar to Satralizumab, such as other anti-IL-6 receptor monoclonal antibodies, can cause injection site reactions, increased risk of infections, and elevated liver enzymes. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Teprotumumab is the first FDA-approved treatment for Thyroid Eye Disease (TED). It is a monoclonal antibody that targets the insulin-like growth factor-1 receptor (IGF-1R) and has been shown to reduce proptosis and improve the quality of life in patients with TED. Other treatments mentioned include Rituximab, an anti-CD20 monoclonal antibody, which has shown efficacy in combination with orbital irradiation. While Satralizumab, an anti-IL-6 receptor monoclonal antibody, is being studied for TED, it has not yet received FDA approval for this indication.

What other types of research exist?

Teprotumumab, an insulin-like growth factor-1 receptor inhibitor, is a promising and novel alternative to Satralizumab for treating Graves' Ophthalmopathy. It has shown significant efficacy and safety in clinical trials and is FDA-approved for this condition.

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Monoclonal Antibodies

Satralizumab for Thyroid Eye Disease (SatraGO-1 Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of thyroid eye disease (TED) based on CAS

Be older than 18 years old

Must not have

Decrease in CAS or proptosis of >= 2 points or >= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24, week 48 and from week 24 to week 48

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Satralizumab may include reactions at the injection site, increased risk of infections due to immune system suppression, liver enzyme elevations, and potential impacts on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with thyroid eye disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My eye condition improved before the study started.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24, week 48 and from week 24 to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24, week 48 and from week 24 to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24, week 48 and from week 24 to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis from Baseline (Day 1) at Week 24 in the Study eye

Secondary study objectives

Change in CAS

Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores

Change in Oxford Corneal Staining Scores

+4 more

Side effects data

From 2021 Phase 3 trial • 85 Patients • NCT02028884

100%

Hypotension

100%

Rash

100%

Haemorrhoids

100%

White blood cell count decreased

100%

Rhinitis

100%

Localised infection

100%

Lymphocyte percentage decreased

100%

Monocyte count increased

100%

White blood cell count increased

100%

Pruritus

100%

Headache

100%

Diarrhoea

100%

Abdominal pain

100%

Tonsillitis

100%

Dysmenorrhoea

100%

Rectal haemorrhage

100%

Ear infection

100%

Neutrophil count increased

100%

Oropharyngeal pain

100%

Haemoglobin decreased

100%

Neutrophil percentage increased

100%

Platelet count increased

100%

Lymphocyte percentage increased

100%

Neutrophil count decreased

100%

80%

60%

40%

20%

Study treatment Arm

Satralizumab Open-Label Period

Placebo + Baseline Treatment Open Label Period

Satralizumab + Baseline Treatment Open Label Period

Satralizumab + Baseline Treatment Double Blind Period

Placebo + Baseline Treatment Double Blind Period

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Satralizumab

2014

Completed Phase 3

~370

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Graves' Ophthalmopathy (GO) is an autoimmune inflammatory disorder affecting the orbit around the eye, often associated with thyroid disease. Treatments targeting the immune system are crucial for managing GO. Satralizumab, an anti-IL-6 receptor monoclonal antibody, works by inhibiting the IL-6 pathway, which plays a significant role in the inflammatory process of GO. By blocking IL-6, Satralizumab reduces inflammation and immune response, potentially alleviating symptoms. Similarly, Rituximab, an anti-CD20 monoclonal antibody, depletes B-cells, which are involved in the autoimmune response, thereby reducing inflammation and tissue damage. Corticosteroids, another common treatment, suppress the overall immune response and inflammation. These treatments are essential for GO patients as they target the underlying autoimmune mechanisms, providing relief from symptoms and preventing disease progression.

Clinical efficacy of combined rituximab treatment in a woman with severe Graves' ophthalmopathy.