Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
NCT ID: NCT05524571
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
2023-01-05
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
2. 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:
* Proptosis ≥ 18 mm and/or
* Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
4. Have onset of active TED within 12 months prior to screening.
5. Have documented evidence of detectable anti-TSHR-Ab at screening.
6. 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.
7. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.
Exclusion Criteria
2. Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
6. 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 -1520
Pasadena, California, United States
Site Number -1517
San Francisco, California, United States
Site Number -1514
Torrance, California, United States
Site Number -1510
Sarasota, Florida, United States
Site Number -1516
Louisville, Kentucky, United States
Site Number - 1526
Livonia, Michigan, United States
Site Number - 1513
Rochester, Minnesota, United States
Site Number - 1512
Winston-Salem, North Carolina, United States
Site Number - 1525
Portland, Oregon, United States
Site Number -1515
Bellaire, Texas, United States
Site Number - 1524
McAllen, Texas, United States
Site Number -1519
San Antonio, Texas, United States
Site Number - 1521
Seattle, Washington, 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 - 4674
Liège, , Belgium
Site Number - 6603
Mainz, Rhineland-Palatinate, Germany
Site Number - 7550
Budapest, , Hungary
Site Number - 7551
Pécs, , Hungary
Site Number - 7552
Pécs, , Hungary
Site Number -9301
Ogre, , Latvia
Site Number -9300
Riga, , Latvia
Site Number - 9302
Ventspils, , Latvia
Site Number - 7570
Christchurch, , New Zealand
Site Number - 7572
Hamilton, , New Zealand
Site Number -1990
San Juan, , Puerto Rico
Site Number - 9203
Bratislava, , Slovakia
Site Number - 9200
Bratislava, , Slovakia
Site Number - 9201
Bratislava, , Slovakia
Site Number - 9202
Trenčín, , Slovakia
Site Number -3602
Barcelona, , Spain
Site Number - 3605
Barcelona, , Spain
Site Number -3601
Madrid, , 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 - 4952
Adana, , Turkey (Türkiye)
Site Number - 4950
Ankara, , Turkey (Türkiye)
Site Number - 4951
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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IMVT-1401-3202
Identifier Type: -
Identifier Source: org_study_id