Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Recruitment Status
TERMINATED
(See Contacts and Locations)Verified March 2026 by Immunovant Sciences GmbH
Sponsor
Immunovant Sciences GmbH
Information Provided by (Responsible Party)
Immunovant Sciences GmbH
Clinicaltrials.gov Identifier
NCT05517447
Other Study ID Numbers:
IMVT-1401-3203
First Submitted
August 23, 2022
First Posted
August 25, 2022
Last Update Posted
April 28, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Thyroid Eye Disease
Other: Observational cohort studyDrug: Batoclimab

Study Design

Study TypeInterventional
Actual Enrollment109 participants
Design AllocationNon-Randomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn 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)
Study Start DateNovember 5, 2022
Actual Primary Completion DateApril 1, 2026
Actual Study Completion DateApril 1, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
Observational cohort
Proptosis responders in feeder studies will enter in a non-treatment observational study
Other: 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
Drug: Batoclimab
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Outcome Measures

Primary Outcome Measures
  1. Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
Secondary Outcome Measures
  1. Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
  2. Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsImmunovant Sciences GmbH
Locations
Site Number - 1520 | Glendora California, United States, 91741Site Number - 1501 | Aurora Colorado, United States, 80045Site Number - 1526 | Livonia Michigan, United States, 48152Site Number - 1513 | Rochester Minnesota, United States, 55905Site Number - 1540 | Las Vegas Nevada, United States, 89184Site Number - 1508 | Houston Texas, United States, 77030Site Number - 1558 | Mesquite Texas, United States, 75149Site Number - 1511 | Morgantown West Virginia, United States, 26506Site Number - 1518 | Milwaukee Wisconsin, United States, 53226Site Number - 7565 | Sydney , Australia, 2000Site Number - 4671 | Bruges , Belgium, 8000Site Number - 4672 | Brussels , Belgium, 1070Site Number - 4673 | Brussels , Belgium, 1200Site Number - 4670 | Ghent , Belgium, B-9000Site Number - 3454 | Tbilisi , Georgia, 114Site Number - 3455 | Tbilisi , Georgia, 114Site Number - 3450 | Tbilisi , Georgia, 159Site Number - 3451 | Tbilisi , Georgia, 159Site Number - 7550 | Budapest , Hungary, 1133Site Number - 7552 | Pécs , Hungary, 7623Site Number - 4760 | Ramat Gan Tel Aviv, Israel, 5265601Site Number - 4764 | Afula , Israel, 1834111Site Number - 4761 | Jerusalem , Israel, 91120Site Number - 4762 | Petah Tikva , Israel, 4941492Site Number - 6207 | Catania , Italy, CAP95125Site Number - 6204 | Milan , Italy, 20122Site Number - 6203 | Milan , Italy, 20149Site Number - 6205 | Naples , Italy, 80131Site Number - 6209 | Palermo , Italy, 90127Site Number - 6201 | Pisa , Italy, 56124Site Number - 6202 | Rome , Italy, 00189Site Number - 9301 | Ogre , Latvia, LV-5001Site Number - 9300 | Riga , Latvia, LV-1006Site Number - 9302 | Ventspils , Latvia, LV3601Site Number - 7570 | Christchurch , New Zealand, 8013Site Number - 3107 | Gliwice Silesian Voivodeship, Poland, 44-102Site Number - 3101 | Krakow , Poland, 30-688Site Number - 3104 | Lublin , Poland, 20-171Site Number - 3105 | Lublin , Poland, 60-354Site Number - 1990 | San Juan , Puerto Rico, 00921Site Number - 9200 | Bratislava , Slovakia, 82606Site Number - 9201 | Bratislava , Slovakia, Site Number - 9202 | Trenčín , Slovakia, 91101Site Number - 3602 | Barcelona Catalonia, Spain, 8006Site Number - 3604 | Madrid , Spain, 28034Site Number - 3600 | Santiago de Compostela , Spain, 15706Site Number - 3606 | Seville , Spain, 41009Site Number - 3603 | Valencia , Spain, 46026Site Number - 7305 | Guildford , United Kingdom, GU2 7XXSite Number - 7303 | London , United Kingdom, EC1V 2PDSite Number - 7312 | London , United Kingdom, W1T 6AHSite Number - 7313 | London , United Kingdom, W1T 7HASite Number - 7300 | Manchester , United Kingdom, M139WLSite Number - 7302 | Newcastle upon Tyne , United Kingdom, NE1 3BZSite Number - 7308 | Sheffield , United Kingdom, S102SB