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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

Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines

Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0: A CAS ≥ 4 in either eye, and clinical evidence of worsened proptosis with: Proptosis ≥ 18 mm and/or Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor

Must not have

Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening

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

Pivotal Trial

Summary

This trial tests the effectiveness of a drug (batoclimab) for a medical condition (proptosis) over the course of 24 weeks.

Who is the study for?

This trial is for adults over 18 with active Thyroid Eye Disease (TED) diagnosed within the last year. Participants should have moderate to severe TED, not require immediate surgery, and have their thyroid disease under control or only mildly off-balance. They can't join if they've had recent steroid treatments, other autoimmune diseases that could affect the study, or past eye surgeries/irradiation for TED.

What is being tested?

The study tests Batoclimab's effectiveness on eye bulging in TED patients. It compares a high dose followed by a lower dose of Batoclimab against a placebo over 24 weeks to see if there's an improvement in proptosis (eye protrusion).

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions at the injection site, immune system responses due to antibody presence in Batoclimab, and potential general medication-related side effects like headaches or fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I have moderate to severe active thyroid eye disease.

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I have severe eye bulging due to thyroid eye disease.

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My tests show I have anti-TSHR antibodies.

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I am 18 years old or older.

Exclusion Criteria

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

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

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

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I have taken steroids equivalent to 1g of methylprednisolone for TED.

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

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My vision has worsened because of optic nerve damage.

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

Diplopia

Percentage of participants with proptosis ≥2 mm reduction and Clinical Activity Score (CAS) of less than or equal to (≤) 3 from Baseline in the study eye

Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score