RECRUITING

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2023-11-06
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05517447

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Have completed the Week 24 visit of the feeder study.
  2. 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.
  3. 2. Did not permanently discontinue batoclimab
  1. 1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Contacts and Locations

Study Contact

Central Study Contact
CONTACT
18007970414
clinicaltrials@immunovant.com

Study Locations (Sites)

Site Number - 1520
Glendora, California, 91741
United States
Site Number - 1501
Aurora, Colorado, 80045
United States
Site Number - 1526
Livonia, Michigan, 48152
United States
Site Number - 1513
Rochester, Minnesota, 55905
United States
Site Number - 1511
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Immunovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-06
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-11-06
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Batoclimab
  • Thyroid eye disease
  • IMVT-1401
  • Monoclonal antibody
  • Autoimmune disorders
  • Graves' Ophthalmopathy
  • Graves' Orbitopathy

Additional Relevant MeSH Terms

  • Thyroid Eye Disease