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, hypertension, diabetes, and osteoporosis. Rituximab, another monoclonal antibody, may lead to infusion reactions, infections, and rare cases of progressive multifocal leukoencephalopathy. 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), also known as Graves' Ophthalmopathy. 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. While Satralizumab, an anti-IL-6 receptor monoclonal antibody, is being studied for its efficacy in TED, other similar treatments like Rituximab, an anti-CD20 monoclonal antibody, have also been explored for their potential benefits in managing the condition.

What other types of research exist?

Teprotumumab, an insulin-like growth factor-1 receptor inhibitor, is a promising alternative to Satralizumab for Graves' Ophthalmopathy patients. It has shown significant efficacy in clinical trials and is FDA-approved for the treatment of Thyroid Eye Disease.

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Monoclonal Antibodies

Satralizumab for Thyroid Eye Disease (SatraGO-2 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 TED based on CAS

Be older than 18 years old

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), confirmed by a clinical diagnosis. Participants must meet specific medical criteria to join.

What is being tested?

The study tests satralizumab, an antibody targeting the IL-6 receptor, against a placebo in patients with TED to evaluate its 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, headaches, and possible abnormalities in liver function tests.

Eligibility Criteria

Inclusion Criteria

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

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 ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye

Secondary study objectives

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

Change in Oxford Corneal Staining Scores

Percentage of Participants Achieving CAS Value of 0 or 1 in the Study eye

+3 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

Anxiety

Flushing

Thermal burn

Neutropenia

Muscle spasms

Hypercholesterolaemia

Myalgia

Hypertension

Blood fibrinogen increased

Bronchitis

Laryngitis

Fall

Ear discomfort

Sinusitis

Rhinorrhoea

Dental caries

Rib fracture

Dyslipidaemia

Blepharitis

Rash

Constipation

Gastritis

Oropharyngeal pain

Blood pressure increased

Pain in extremity

Cystitis

Prothrombin time prolonged

Hypocomplementaemia

Blood fibrinogen decreased

Lymphocyte percentage increased

Vomiting

Toothache

Forearm fracture

Influenza

Hordeolum

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

White blood cell count decreased

Blood creatine phosphokinase increased

Tonsillitis

Pharyngitis

Urticaria

Neutrophil count increased

Haemoglobin decreased

Upper limb fracture

Cervical dysplasia

Parkinsonism

Aspartate aminotransferase increased

Gait disturbance

Neutrophil percentage increased

Spinal compression fracture

Dizziness

Neutrophil count decreased

Non-cardiac chest pain

Hepatitis E

Iron deficiency anaemia

100%

80%

60%

40%

20%

Study treatment Arm

Satralizumab + Baseline Treatment Open Label Period

Placebo + 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 / 1Eligibility 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 condition where the immune system attacks the tissues around the eyes, leading to inflammation and tissue remodeling. Common treatments include immunomodulatory therapies such as monoclonal antibodies. Satralizumab, an anti-IL-6 receptor monoclonal antibody, works by inhibiting the interleukin-6 (IL-6) pathway, which plays a crucial role in the inflammatory process. By blocking IL-6, Satralizumab reduces inflammation and immune response, potentially alleviating symptoms of GO. Similarly, Rituximab, an anti-CD20 monoclonal antibody, targets B-cells, reducing their activity and subsequent antibody production, which also helps in decreasing inflammation and tissue damage. These treatments are significant for GO patients as they directly address the underlying immune mechanisms, offering potential for better disease control and symptom relief.

Graves' disease: developments in first-line antithyroid drugs in the young.Clinical efficacy of combined rituximab treatment in a woman with severe Graves' ophthalmopathy.