Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
NCT ID: NCT05517447
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2022-11-06
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Observational cohort
Proptosis responders in feeder studies will enter in a non-treatment observational study
Observational cohort study
Observational cohort study
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
Batoclimab
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Interventions
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Observational cohort study
Observational cohort study
Batoclimab
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
1\. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
18 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Site Number - 1520
Glendora, California, United States
Site Number - 1501
Aurora, Colorado, United States
Site Number - 1526
Livonia, Michigan, United States
Site Number - 1513
Rochester, Minnesota, United States
Site Number - 1540
Las Vegas, Nevada, United States
Site Number - 1508
Houston, Texas, United States
Site Number - 1558
Mesquite, Texas, United States
Site Number - 1511
Morgantown, West Virginia, United States
Site Number - 1518
Milwaukee, Wisconsin, United States
Site Number - 7565
Sydney, , Australia
Site Number - 4671
Bruges, , Belgium
Site Number - 4672
Brussels, , Belgium
Site Number - 4673
Brussels, , Belgium
Site Number - 4670
Ghent, , Belgium
Site Number - 3454
Tbilisi, , Georgia
Site Number - 3455
Tbilisi, , Georgia
Site Number - 3450
Tbilisi, , Georgia
Site Number - 3451
Tbilisi, , Georgia
Site Number - 7550
Budapest, , Hungary
Site Number - 7552
Pécs, , Hungary
Site Number - 4760
Ramat Gan, Tel Aviv, Israel
Site Number - 4764
Afula, , Israel
Site Number - 4761
Jerusalem, , Israel
Site Number - 4762
Petah Tikva, , Israel
Site Number - 6207
Catania, , Italy
Site Number - 6204
Milan, , Italy
Site Number - 6203
Milan, , Italy
Site Number - 6205
Napoli, , Italy
Site Number - 6209
Palermo, , Italy
Site Number - 6201
Pisa, , Italy
Site Number - 6202
Rome, , Italy
Site Number - 9301
Ogre, , Latvia
Site Number - 9300
Riga, , Latvia
Site Number - 9302
Ventspils, , Latvia
Site Number - 7570
Christchurch, , New Zealand
Site Number - 3107
Gliwice, Silesian Voivodeship, Poland
Site Number - 3101
Krakow, , Poland
Site Number - 3104
Lublin, , Poland
Site Number - 3105
Lublin, , Poland
Site Number - 1990
San Juan, , Puerto Rico
Site Number - 9200
Bratislava, , Slovakia
Site Number - 9201
Bratislava, , Slovakia
Site Number - 9202
Trenčín, , Slovakia
Site Number - 3602
Barcelona, Catalonia, Spain
Site Number - 3604
Madrid, , Spain
Site Number - 3600
Santiago de Compostela, , Spain
Site Number - 3606
Seville, , Spain
Site Number - 3603
Valencia, , Spain
Site Number - 7305
Guildford, , United Kingdom
Site Number - 7303
London, , United Kingdom
Site Number - 7312
London, , United Kingdom
Site Number - 7313
London, , United Kingdom
Site Number - 7300
Manchester, , United Kingdom
Site Number - 7302
Newcastle upon Tyne, , United Kingdom
Site Number - 7308
Sheffield, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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IMVT-1401-3203
Identifier Type: -
Identifier Source: org_study_id
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