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Assessing Batoclimab for Thyroid Eye Disease

An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)

Phase 3 Interventional Immunovant Sciences GmbH · NCT05517447

This study is testing if a drug called batoclimab can help people with thyroid eye disease keep their eye bulging under control after they’ve finished previous treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorImmunovant Sciences GmbH Industry-sponsored
Drugs / interventionsbatoclimab
Locations44 sites (Glendora, California and 43 other locations)
Trial IDNCT05517447 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals who have completed the Week 24 visit of the feeder studies and do not require immediate surgical intervention.

Not a fit: Patients who have permanently discontinued batoclimab or require immediate surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from thyroid eye disease.

How similar studies have performed: Other studies involving monoclonal antibodies for autoimmune disorders have shown promising results, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Glendora, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thyroid Eye DiseaseBatoclimabThyroid eye diseaseIMVT-1401Monoclonal antibodyAutoimmune disordersGraves' OphthalmopathyGraves' Orbitopathy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.