← Back to Search

Monoclonal Antibodies

Batoclimab for Thyroid 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
Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is an extension study for participants who have completed earlier studies. There are two groups in the study: an observational group and a treatment group. The observational group will look at how long the improvement

Who is the study for?
This trial is for individuals who have completed a previous study on thyroid eye disease (TED) at week 24, don't need urgent surgery, and haven't stopped using batoclimab permanently. They should not be planning any corrective procedures or other medical treatments for TED during the study.
What is being tested?
The trial has two parts: one where participants are observed to see how long their improvement in eye bulging lasts without treatment, and another where the effectiveness of batoclimab is tested by checking if it reduces eye bulging.
What are the potential side effects?
While specific side effects of batoclimab aren't listed here, similar medications can cause reactions at the injection site, muscle pain, headaches, general discomfort or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I don't need surgery or specific treatments for thyroid eye disease during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment CohortExperimental Treatment1 Intervention
Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks
Group II: Observational cohortExperimental Treatment1 Intervention
Proptosis responders in feeder studies will enter in a non-treatment observational study

Find a Location

Who is running the clinical trial?

Immunovant Sciences GmbHLead Sponsor
9 Previous Clinical Trials
856 Total Patients Enrolled
~74 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top