Batoclimab for Thyroid Eye Disease

Recruiting in Palo Alto (17 mi)

+92 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Immunovant Sciences GmbH

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Do you have Thyroid Eye Disease diagnosed in the last year?

Exclusion Criteria

Have you ever taken Tepezza to treat your Thyroid Eye Disease?

Participant Groups

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).

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.

Batoclimab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Batoclimab for: