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Search / Trial NCT05517447

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Launched by IMMUNOVANT SCIENCES GMBH · Aug 24, 2022

Trial Information

Current as of June 08, 2025

Recruiting

Keywords

Batoclimab Thyroid Eye Disease Imvt 1401 Monoclonal Antibody Autoimmune Disorders Graves' Ophthalmopathy Graves' Orbitopathy

ClinConnect Summary

This clinical trial is studying a treatment called batoclimab for people with Thyroid Eye Disease, a condition that can cause eye bulging and discomfort. The trial has two parts: one part is observing participants who have completed earlier studies to see how long their symptoms remain improved after stopping treatment, while the other part involves giving batoclimab to participants to see how effective it is at reducing eye bulging.

To be eligible for this study, participants must have finished a previous study and should not need immediate surgery or other treatments for their eye condition during the trial. It’s important that those who join the treatment group have not stopped taking batoclimab permanently. Participants in the trial can expect regular check-ins to monitor their progress and learn more about how batoclimab works for their condition. This is a great opportunity for individuals looking for potential new treatments for their Thyroid Eye Disease.

Gender

ALL

Eligibility 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.

About Immunovant Sciences Gmbh

Immunovant Sciences GmbH is a biopharmaceutical company focused on advancing innovative therapies for patients with autoimmune diseases. Leveraging a deep understanding of the immune system, the company is dedicated to developing monoclonal antibodies that target specific pathways to provide safer and more effective treatment options. With a commitment to scientific excellence and patient-centric approaches, Immunovant aims to address unmet medical needs and improve the quality of life for individuals affected by debilitating conditions. Through rigorous clinical trials and collaborations, the company strives to bring transformative therapies to market, reinforcing its position as a leader in the field of immunology.

Locations

Brugge, , Belgium

Rochester, Minnesota, United States

Budapest, , Hungary

Houston, Texas, United States

Napoli, , Italy

Lublin, , Poland

Guildford, , United Kingdom

Bratislava, , Slovakia

Jerusalem, , Israel

Livonia, Michigan, United States

Milwaukee, Wisconsin, United States

Bruxelles, , Belgium

Bruxelles, , Belgium

Ramat Gan, , Israel

London, , United Kingdom

Glendora, California, United States

Valencia, , Spain

Christchurch, , New Zealand

Ogre, , Latvia

Trenčín, , Slovakia

Kraków, , Poland

Brugge, , Belgium

Gent, , Belgium

Las Vegas, Nevada, United States

Sheffield, , United Kingdom

Ventspils, , Latvia

Barcelona, Catalonia, Spain

Sevilla, , Spain

Aurora, Colorado, United States

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Lublin, , Poland

Pécs, , Hungary

Riga, , Latvia

Bratislava, , Slovakia

London, , United Kingdom

Petah Tikva, , Israel

San Juan, , Puerto Rico

Madrid, , Spain

Tbilisi, , Georgia

Afula, , Israel

Rome, , Italy

Santiago De Compostela, , Spain

Morgantown, West Virginia, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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