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

21%

Upper respiratory tract infection

18%

Nasopharyngitis

15%

Headache

13%

Urinary tract infection

13%

Alanine aminotransferase increased

13%

Anaemia

11%

Alopecia

11%

Hyperlipidaemia

11%

Vertigo

11%

Chest discomfort

11%

Complement factor decreased

11%

Conjunctivitis

10%

Lymphopenia

10%

Leukopenia

Arthralgia

Cough

Eczema

Conjunctival haemorrhage

Diarrhoea

Oral herpes

Oral candidiasis

Bradycardia

Hypertransaminasaemia

Retinal haemorrhage

Hypofibrinogenaemia

Left ventricle outflow tract obstruction

Blepharospasm

Conjunctival deposit

Dry eye

Glaucoma

Excoriation

Blood urine

Protein urine present

Dehydration

Amenorrhoea

Pharyngeal erythema

Acne

Intervertebral disc protrusion

Muscle spasticity

Blood alkaline phosphatase increased

Polycythaemia

Oedema peripheral

Bacteriuria

Pyelonephritis

Respiratory tract infection

Wound

Epistaxis

Musculoskeletal stiffness

Large intestine polyp

Pancreatitis acute

Feeling abnormal

Hepatic function abnormal

Arthropod sting

Feeling hot

Pelvic fracture

Osteoarthritis

Nephrolithiasis

Platelet count decreased

Cataract

Chills

Contusion

Serum ferritin decreased

Dyspepsia

Onychomycosis

Viral upper respiratory tract infection

Upper respiratory tract inflammation

Plicated tongue

Compression fracture

Urobilinogen urine increased

Neck pain

Malaise

Angina pectoris

Abdominal distension

Cellulitis

Enterocolitis infectious

Pneumonia

Joint injury

Weight increased

Myopathy toxic

Spinal osteoarthritis

Epilepsy

Lower limb fracture

Low density lipoprotein increased

Weight decreased

Iron deficiency

Erythema

Rash pruritic

Spinal pain

Intercostal neuralgia

Eye pruritus

Panic disorder

Hypertension

Flushing

Anxiety

Blood pressure increased

Thermal burn

Neutropenia

Muscle spasms

Hypercholesterolaemia

Myalgia

Blood fibrinogen increased

Bronchitis

Laryngitis

Fall

Ear discomfort

Sinusitis

Rhinorrhoea

Dental caries

Rib fracture

Dyslipidaemia

Blepharitis

Rash

Constipation

Gastritis

Oropharyngeal pain

Pain in extremity

Cystitis

Prothrombin time prolonged

Hypocomplementaemia

Blood fibrinogen decreased

Influenza

Dizziness

Lymphocyte percentage increased

Vomiting

Toothache

Forearm fracture

White blood cell count decreased

Hordeolum

Aspartate aminotransferase increased

Periodontitis

Haemorrhoids

Lymphocyte count decreased

Large intestine infection

Rhinitis

Back pain

White blood cell count increased

Abdominal pain upper

Insomnia

Neuromyelitis optica pseudo relapse

Lumbar spinal stenosis

Blood creatine phosphokinase increased

Tonsillitis

Pharyngitis

Urticaria

Neutrophil count increased

Haemoglobin decreased

Upper limb fracture

Cervical dysplasia

Parkinsonism

Gait disturbance

Neutrophil percentage increased

Spinal compression fracture

Neutrophil count decreased

Non-cardiac chest pain

Hepatitis E

Iron deficiency anaemia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Baseline Treatment Open Label Period

Satralizumab + Baseline Treatment Open Label Period

Satralizumab 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.