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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 1Eligibility criteria met