Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

April 24, 2026 updated by: Immunovant Sciences GmbH

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia, 2000
        • Site Number - 7565
  • Belgium
      • Bruges, Belgium, 8000
        • Site Number - 4671
      • Brussels, Belgium, 1070
        • Site Number - 4672
      • Brussels, Belgium, 1200
        • Site Number - 4673
      • Ghent, Belgium, B-9000
        • Site Number - 4670
  • Georgia
      • Tbilisi, Georgia, 114
        • Site Number - 3454
      • Tbilisi, Georgia, 114
        • Site Number - 3455
      • Tbilisi, Georgia, 159
        • Site Number - 3450
      • Tbilisi, Georgia, 159
        • Site Number - 3451
  • Hungary
      • Budapest, Hungary, 1133
        • Site Number - 7550
      • Pécs, Hungary, 7623
        • Site Number - 7552
  • Israel
      • Afula, Israel, 1834111
        • Site Number - 4764
      • Jerusalem, Israel, 91120
        • Site Number - 4761
      • Petah Tikva, Israel, 4941492
        • Site Number - 4762
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • Site Number - 4760
  • Italy
      • Catania, Italy, CAP95125
        • Site Number - 6207
      • Milan, Italy, 20122
        • Site Number - 6204
      • Milan, Italy, 20149
        • Site Number - 6203
      • Naples, Italy, 80131
        • Site Number - 6205
      • Palermo, Italy, 90127
        • Site Number - 6209
      • Pisa, Italy, 56124
        • Site Number - 6201
      • Rome, Italy, 00189
        • Site Number - 6202
  • Latvia
      • Ogre, Latvia, LV-5001
        • Site Number - 9301
      • Riga, Latvia, LV-1006
        • Site Number - 9300
      • Ventspils, Latvia, LV3601
        • Site Number - 9302
  • New Zealand
      • Christchurch, New Zealand, 8013
        • Site Number - 7570
  • Poland
      • Krakow, Poland, 30-688
        • Site Number - 3101
      • Lublin, Poland, 20-171
        • Site Number - 3104
      • Lublin, Poland, 60-354
        • Site Number - 3105
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-102
        • Site Number - 3107
  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • Site Number - 1990
  • Slovakia
      • Bratislava, Slovakia, 82606
        • Site Number - 9200
      • Bratislava, Slovakia
        • Site Number - 9201
      • Trenčín, Slovakia, 91101
        • Site Number - 9202
  • Spain
      • Madrid, Spain, 28034
        • Site Number - 3604
      • Santiago de Compostela, Spain, 15706
        • Site Number - 3600
      • Seville, Spain, 41009
        • Site Number - 3606
      • Valencia, Spain, 46026
        • Site Number - 3603
    • Catalonia
      • Barcelona, Catalonia, Spain, 8006
        • Site Number - 3602
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Site Number - 7305
      • London, United Kingdom, EC1V 2PD
        • Site Number - 7303
      • London, United Kingdom, W1T 6AH
        • Site Number - 7312
      • London, United Kingdom, W1T 7HA
        • Site Number - 7313
      • Manchester, United Kingdom, M139WL
        • Site Number - 7300
      • Newcastle upon Tyne, United Kingdom, NE1 3BZ
        • Site Number - 7302
      • Sheffield, United Kingdom, S102SB
        • Site Number - 7308
  • United States
    • California
      • Glendora, California, United States, 91741
        • Site Number - 1520
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site Number - 1501
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Site Number - 1526
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Site Number - 1513
    • Nevada
      • Las Vegas, Nevada, United States, 89184
        • Site Number - 1540
    • Texas
      • Houston, Texas, United States, 77030
        • Site Number - 1508
      • Mesquite, Texas, United States, 75149
        • Site Number - 1558
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Site Number - 1511
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Site Number - 1518

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Observational cohort
Proptosis responders in feeder studies will enter in a non-treatment observational study
Other: Observational cohort study
Observational cohort study
Experimental: Treatment Cohort
Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks
Drug: Batoclimab
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
Time Frame: Up to Week 24
Up to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
Time Frame: At Week 24
At Week 24
Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies
Time Frame: At Week 24
At Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

November 6, 2022

Primary Completion (Actual)

April 2, 2026

Study Completion (Actual)

April 2, 2026

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1401-3203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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