Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
NCT ID: NCT05517421
Last Updated: 2025-11-06
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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ACTIVE_NOT_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2022-11-23
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Batoclimab
Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
Batoclimab
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Placebo
Participants will be administered matching placebo SC weekly for 24 weeks.
Placebo
Matching Placebo
Interventions
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Batoclimab
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Placebo
Matching Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:
* A CAS ≥ 4 in either eye, and
* Clinical evidence of worsened proptosis with:
1. Proptosis ≥ 18 mm and/or
2. Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
* Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
* Have onset of active TED within 12 months prior to screening.
* Have documented evidence of detectable anti-TSHR-Ab at screening.
* Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
* Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism.
Exclusion Criteria
* Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
* Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
* Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
* Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
* Had previous orbital irradiation or surgery for TED.
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 - 1557
Beverly Hills, California, United States
Site Number - 1539
Carlsbad, California, United States
Site Number - 1502
Los Angeles, California, United States
Site Number - 1505
Los Angeles, California, United States
Site Number - 1532
Los Angeles, California, United States
Site Number - 1537
San Diego, California, United States
Site Number - 1531
Torrance, California, United States
Site Number - 1501
Aurora, Colorado, United States
Site Number - 1544
Longmont, Colorado, United States
Site Number - 1547
Newark, Delaware, United States
Site Number - 1504
Miami, Florida, United States
Site Number - 1538
Port Charlotte, Florida, United States
Site Number - 1542
Tampa, Florida, United States
Site Number - 1536
West Palm Beach, Florida, United States
Site Number - 1554
Stockbridge, Georgia, United States
Site Number - 1534
Chicago, Illinois, United States
Site Number - 1545
Iowa City, Iowa, United States
Site Number - 1535
Baltimore, Maryland, United States
Site Number - 1506
Boston, Massachusetts, United States
Site Number - 1540
Las Vegas, Nevada, United States
Site Number - 1530
Chapel Hill, North Carolina, United States
Site Number - 1550
Columbus, Ohio, United States
Site Number - 1507
Portland, Oregon, United States
Site Number - 1556
Warwick, Rhode Island, United States
Site Number - 1551
Dallas, Texas, United States
Site Number - 1508
Houston, Texas, United States
Site Number - 1558
Mesquite, Texas, United States
Site Number - 1500
Roanoke, Virginia, United States
Site Number - 1509
Madison, Wisconsin, United States
Site Number - 2502
Edmonton, Alberta, Canada
Site Number - 2500
Ottawa, Ontario, Canada
Site Number - 2501
Montreal, Quebec, Canada
Site Number - 3452
Tbilisi, , Georgia
Site Number - 3454
Tbilisi, , Georgia
Site Number - 3455
Tbilisi, , Georgia
Site Number - 3450
Tbilisi, , Georgia
Site Number - 3451
Tbilisi, , Georgia
Site Number - 3453
Tbilisi, , Georgia
Site Number - 6609
Tübingen, Baden - Wuttemberg, Germany
Site Number - 6608
Frankfurt am Main, Hesse, Germany
Site Number - 6604
Mainz, Rhineland-Palatinate, Germany
Site Number - 6610
Leipzig, Saxony, Germany
Site Number - 6611
Schwerin, , Germany
Site Number - 4764
Afula, , Israel
Site Number - 4761
Jerusalem, , Israel
Site Number - 4763
Nahariya, , Israel
Site Number - 4762
Petah Tikva, , Israel
Site Number - 4760
Ramat Gan, , Israel
Site Number - 6206
Bologna, , Italy
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 - 6200
Pisa, , Italy
Site Number - 6201
Pisa, , Italy
Site Number - 6202
Roma, , Italy
Site Number - 6208
Rome, , Italy
Site Number - 7415
Maebashi, Gunma, Japan
Site Number- 7418
Hokkaido, Sapporo, Japan
Site Number - 7401
Fukuoka, , Japan
Site Number - 7403
Hyōgo, , Japan
Site Number - 7411
Ibaraki, , Japan
Site Number - 7410
Kanagawa, , Japan
Site Number - 7402
Kitakyushu, , Japan
Site Number - 7417
Kobe, , Japan
Site Number - 7416
Kumamoto, , Japan
Site Number - 7414
Miyazaki, , Japan
Site Number - 7407
Nagasaki, , Japan
Site Number - 7406
Nagoya, , Japan
Site Number - 7412
Nankoku, , Japan
Site Number - 7408
Osaka, , Japan
Site Number - 7409
Tokyo, , Japan
Site Number - 7404
Tottori, , Japan
Site Number - 7413
Yamaguchi, , Japan
Site Number - 3107
Gliwice, , Poland
Site Number - 3103
Katowice, , Poland
Site Number - 3101
Krakow, , Poland
Site Number - 3104
Lublin, , Poland
Site Number - 3102
Lublin, , Poland
Site Number - 3105
Lublin, , Poland
Site Number - 3106
Olsztyn, , Poland
Site Number - 3100
Warsaw, , Poland
Site Number - 7305
Guildford, , United Kingdom
Site Number - 7310
Hull, , United Kingdom
Site Number - 7309
Leicester, , United Kingdom
Site Number - 7303
London, , United Kingdom
Site Number - 7311
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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Other Identifiers
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IMVT-1401-3201
Identifier Type: -
Identifier Source: org_study_id