Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Description

This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.

Conditions

Thyroid Eye Disease

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Study Overview

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Study Details

Study overview

This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.

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)

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Condition
Thyroid Eye Disease
Intervention / Treatment

-

Contacts and Locations

Glendora

Site Number - 1520, Glendora, California, United States, 91741

Aurora

Site Number - 1501, Aurora, Colorado, United States, 80045

Livonia

Site Number - 1526, Livonia, Michigan, United States, 48152

Rochester

Site Number - 1513, Rochester, Minnesota, United States, 55905

Morgantown

Site Number - 1511, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Have completed the Week 24 visit of the feeder study.
  • 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
  • 1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovant Sciences GmbH,

Study Record Dates

2025-06