Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
- Conditions
- Thyroid Eye Disease
- Interventions
- Other: Observational cohort study
- Registration Number
- NCT05517447
- Lead Sponsor
- Immunovant Sciences GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Observational cohort Observational cohort study Proptosis responders in feeder studies will enter in a non-treatment observational study Treatment Cohort Batoclimab 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
- Primary Outcome Measures
Name Time Method Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies Up to Week 24
- Secondary Outcome Measures
Name Time Method Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies At Week 24 Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies At Week 24
Trial Locations
- Locations (44)
Site Number - 1508
🇺🇸Houston, Texas, United States
Site Number - 3455
🇬🇪Tbilisi, Georgia
Site Number - 3451
🇬🇪Tbilisi, Georgia
Site Number - 3105
🇵🇱Lublin, Poland
Site Number - 7303
🇬🇧London, United Kingdom
Site Number - 7312
🇬🇧London, United Kingdom
Site Number - 1520
🇺🇸Glendora, California, United States
Site Number - 1540
🇺🇸Las Vegas, Nevada, United States
Site Number - 3454
🇬🇪Tbilisi, Georgia
Site Number - 4761
🇮🇱Jerusalem, Israel
Site Number - 9302
🇱🇻Ventspils, Latvia
Site Number - 1501
🇺🇸Aurora, Colorado, United States
Site Number - 1513
🇺🇸Rochester, Minnesota, United States
Site Number - 4671
🇧🇪Brugge, Belgium
Site Number - 4673
🇧🇪Bruxelles, Belgium
Site Number - 7552
🇭🇺Pécs, Hungary
Site Number - 1526
🇺🇸Livonia, Michigan, United States
Site Number - 1518
🇺🇸Milwaukee, Wisconsin, United States
Site Number - 7550
🇭🇺Budapest, Hungary
Site Number - 1511
🇺🇸Morgantown, West Virginia, United States
Site Number - 4672
🇧🇪Bruxelles, Belgium
Site Number - 4670
🇧🇪Gent, Belgium
Site Number - 6205
🇮🇹Napoli, Italy
Site Number - 9301
🇱🇻Ogre, Latvia
Site Number - 1990
🇵🇷San Juan, Puerto Rico
Site Number - 3450
🇬🇪Tbilisi, Georgia
Site Number - 4760
🇮🇱Ramat Gan, Tel Aviv, Israel
Site Number - 4764
🇮🇱Afula, Israel
Site Number - 4762
🇮🇱Petah tikva, Israel
Site Number - 9300
🇱🇻Riga, Latvia
Site Number - 7570
🇳🇿Christchurch, New Zealand
Site Number - 3101
🇵🇱Kraków, Poland
Site Number - 3104
🇵🇱Lublin, Poland
Site Number - 6202
🇮🇹Rome, Italy
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
🇪🇸Sevilla, Spain
Site Number - 3603
🇪🇸Valencia, Spain
Site Number - 7305
🇬🇧Guildford, United Kingdom
Site Number - 7308
🇬🇧Sheffield, United Kingdom