Assessing Batoclimab for Thyroid Eye Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This extension study involves two cohorts: an observational cohort that evaluates the durability of proptosis response after participants have completed feeder studies, and a treatment cohort that assesses the efficacy of batoclimab in improving proptosis rates. Participants must have completed a prior study and will be monitored for their response to treatment. The study aims to gather additional data on the long-term effects of batoclimab in patients with thyroid eye disease.

Why it matters

Who can join: the full rules

Inclusion criteria:

For all participants:

1. Have completed the Week 24 visit of the feeder study.

For participants assigned to the Open-label Treatment Cohort:

1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
2. Did not permanently discontinue batoclimab

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

For all participants:

1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Where it's running

• Site Number - 1501
  Aurora, Colorado, United States Recruiting
• Site Number - 1526
  Livonia, Michigan, United States Recruiting
• Site Number - 1513
  Rochester, Minnesota, United States Recruiting
• Site Number - 1540
  Las Vegas, Nevada, United States Recruiting
• Site Number - 1508
  Houston, Texas, United States Recruiting
• Site Number - 1511
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Study coordinator: Central Study Contact
• Email: clinicaltrials@immunovant.com
• Phone: 18007970414

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• IBI3031 in Thyroid Eye Disease (TED)

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• AMG 732 for thyroid eye disease in a rollover, open-label study

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• Teprotumumab N01 for adults with thyroid eye disease

  This will try Teprotumumab N01 in adults with recent-onset thyroid eye disease to see if it reduces eye inflammation and improves vision and quality of life.

  Recruiting Peking University Third Hospital · Beijing · NCT07423013

• Teprotumumab N01 vs IV steroids for active thyroid eye disease

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  Recruiting Phase 4 Innovent Biologics (Suzhou) Co. Ltd. · Shanghai, Shanghai Municipality · NCT07265258

• Testing IBI311 for inactive thyroid eye disease.

  This trial will test whether IBI311 improves eye signs and symptoms and is safe for people with inactive thyroid eye disease.

  Recruiting Phase 3 Innovent Biologics (Suzhou) Co. Ltd. · Shenyang, Liaoning · NCT07113262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.