What side effects are associated with this type of intervention?

Common treatments for Graves' Ophthalmopathy include corticosteroids, radiation therapy, and surgical interventions. Corticosteroids, such as prednisone, can cause side effects like weight gain, mood swings, high blood pressure, and increased risk of infections. Radiation therapy may lead to dry eyes, cataracts, and, rarely, retinal damage. Surgical options, including orbital decompression, can result in complications such as double vision and infection. Treatments similar to Batoclimab, which involves FcRn inhibition, are still under investigation, but potential side effects may include injection site reactions, increased risk of infections, and hypersensitivity reactions.

What prior FDA approvals exist?

Teprotumumab, an IGF-1R antibody, is an FDA-approved treatment for Thyroid Eye Disease (TED), a condition associated with Graves' Ophthalmopathy. It has been shown to significantly reduce the signs of active TED. While Batoclimab, an FcRn inhibitor, is still under study, Teprotumumab represents a similar approach in targeting immune pathways to manage the disease. Other treatments for Graves' Ophthalmopathy include corticosteroids and immunosuppressive therapies, but these are not as specifically targeted as Teprotumumab.

What other types of research exist?

Promising novel alternatives to Batoclimab for Graves' Ophthalmopathy include Teprotumumab, a monoclonal antibody targeting the IGF-1 receptor, which has shown significant efficacy in reducing proptosis and inflammation in clinical trials. Another potential alternative is Rituximab, a monoclonal antibody against CD20, which has been explored for its immunomodulatory effects in autoimmune conditions. Additionally, emerging biologic therapies targeting specific cytokines involved in the inflammatory process, such as IL-6 inhibitors (e.g., Tocilizumab), may also offer new treatment options.

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Monoclonal Antibodies

Batoclimab for Graves' Eye Disease

Phase 3

Recruiting

Research Sponsored by Immunovant Sciences GmbH

Eligibility Criteria Checklist

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

Must have

Are ≥18 years of age at screening.

Have a clinical diagnosis of TED associated with active, moderate to severe TED with a CAS ≥4 in either eye at screening and Baseline.

Must not have

Have decreased best corrected visual acuity due to optic neuropathy.

Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 24

Awards & highlights

Summary

This trial tests batoclimab, a medication given as weekly injections under the skin, to see if it can help reduce eye bulging in patients with proptosis. The treatment starts with a higher dose for a few months, followed by a lower dose for a few more months. Batoclimab works by adjusting the immune system to decrease inflammation and swelling around the eyes.

Who is the study for?

This trial is for adults over 18 with active, moderate to severe Thyroid Eye Disease (TED) diagnosed within the last year. Participants should not be planning surgery or other treatments for TED during the study and must have their thyroid disease under control. They cannot join if they've had recent steroid treatment, eye surgery, or irradiation, or if they have other autoimmune diseases that could affect the study.

What is being tested?

The trial tests Batoclimab's effectiveness against a placebo in reducing eye bulging in TED patients. For 24 weeks, participants will receive either Batoclimab injections weekly—higher dose first then lower—or a dummy injection without any medication (placebo).

What are the potential side effects?

While specific side effects of Batoclimab are not listed here, similar medications can cause reactions at the injection site, headaches, muscle pains and potentially impact immune function leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with severe thyroid eye disease.

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I have moderate to severe active thyroid eye disease.

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My tests show I have detectable thyroid-stimulating hormone receptor antibodies.

Exclusion Criteria

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

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My vision has worsened because of optic nerve damage.

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My eye condition improved by at least 2 points or my eye bulging reduced by 2 mm before the study starts.

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I have not used steroids for TED or any condition in the last 4 weeks.

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I have taken a high dose of steroids for thyroid eye disease.

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I have had eye surgery or radiation for thyroid eye disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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 proptosis responders

Secondary study objectives

Mean change from Baseline in CAS in the study eye

Mean change from Baseline in proptosis in the study eye

Percentage of participants with CAS of 0 or 1 in the study eye

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BatoclimabExperimental Treatment1 Intervention

Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be administered matching placebo SC weekly for 24 weeks.

0 / 9Eligibility 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

Common treatments for Graves' Ophthalmopathy include glucocorticoids, which reduce inflammation by inhibiting peripheral T4 to T3 conversion and thyroid secretion, and intravenous immune globulin (IVIG), which modulates the immune response. Batoclimab, an FcRn inhibitor, works by reducing the levels of pathogenic IgG antibodies, thereby decreasing inflammation and autoimmunity. These mechanisms are crucial for Graves' Ophthalmopathy patients as they target the underlying autoimmune process, reducing inflammation and preventing further tissue damage around the eyes.