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Monoclonal Antibodies

Satralizumab for Thyroid Eye Disease

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
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 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

Side effects data

From 2021 Phase 3 trial • 85 Patients • NCT02028884
100%
Haemorrhoids
100%
Rhinitis
100%
Rash
100%
Hypotension
100%
Monocyte count increased
100%
Localised infection
100%
Pruritus
100%
Rectal haemorrhage
100%
Diarrhoea
100%
Abdominal pain
100%
Ear infection
100%
Headache
100%
Dysmenorrhoea
100%
White blood cell count decreased
100%
Oropharyngeal pain
100%
Tonsillitis
100%
Haemoglobin decreased
100%
Neutrophil count increased
100%
White blood cell count increased
100%
Lymphocyte percentage decreased
100%
Lymphocyte percentage increased
100%
Neutrophil percentage increased
100%
Platelet count increased
100%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
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

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 every 4 weeks (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
~180

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.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,093,002 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
892,296 Total Patients Enrolled
~37 spots leftby Mar 2025
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