An 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)
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ For all participants:
⁃ 1\. Have completed the Week 24 visit of the feeder study.
⁃ For participants assigned to the Open-label Treatment Cohort:
• Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
• Did not permanently discontinue batoclimab
⁃ Additional inclusion criteria are defined in the protocol.
Locations
United States
California
Site Number - 1520
COMPLETED
Glendora
Colorado
Site Number - 1501
RECRUITING
Aurora
Michigan
Site Number - 1526
RECRUITING
Livonia
Minnesota
Site Number - 1513
RECRUITING
Rochester
Nevada
Site Number - 1540
RECRUITING
Las Vegas
Texas
Site Number - 1508
RECRUITING
Houston
Site Number - 1558
RECRUITING
Mesquite
Wisconsin
Site Number - 1518
RECRUITING
Milwaukee
West Virginia
Site Number - 1511
RECRUITING
Morgantown
Other Locations
Australia
Site Number - 7565
RECRUITING
Sydney
Belgium
Site Number - 4671
RECRUITING
Bruges
Site Number - 4672
RECRUITING
Brussels
Site Number - 4673
RECRUITING
Brussels
Site Number - 4670
RECRUITING
Ghent
Georgia
Site Number - 3450
RECRUITING
Tbilisi
Site Number - 3451
RECRUITING
Tbilisi
Site Number - 3454
RECRUITING
Tbilisi
Site Number - 3455
RECRUITING
Tbilisi
Hungary
Site Number - 7550
RECRUITING
Budapest
Site Number - 7552
RECRUITING
Pécs
Israel
Site Number - 4764
RECRUITING
Afula
Site Number - 4761
RECRUITING
Jerusalem
Site Number - 4762
RECRUITING
Petah Tikva
Site Number - 4760
RECRUITING
Ramat Gan
Italy
Site Number - 6207
RECRUITING
Catania
Site Number - 6203
RECRUITING
Milan
Site Number - 6205
RECRUITING
Napoli
Site Number - 6201
RECRUITING
Pisa
Site Number - 6202
RECRUITING
Rome
Latvia
Site Number - 9301
RECRUITING
Ogre
Site Number - 9300
RECRUITING
Riga
Site Number - 9302
RECRUITING
Ventspils
New Zealand
Site Number - 7570
RECRUITING
Christchurch
Poland
Site Number - 3107
RECRUITING
Gliwice
Site Number - 3101
RECRUITING
Krakow
Site Number - 3104
RECRUITING
Lublin
Site Number - 3105
RECRUITING
Lublin
Puerto Rico
Site Number - 1990
RECRUITING
San Juan
Slovakia
Site Number - 9200
RECRUITING
Bratislava
Site Number - 9201
RECRUITING
Bratislava
Site Number - 9202
RECRUITING
Trenčín
Spain
Site Number - 3602
RECRUITING
Barcelona
Site Number - 3604
RECRUITING
Madrid
Site Number - 3600
RECRUITING
Santiago De Compostela
Site Number - 3606
RECRUITING
Seville
Site Number - 3603
RECRUITING
Valencia
United Kingdom
Site Number - 7305
RECRUITING
Guildford
Site Number - 7303
RECRUITING
London
Site Number - 7312
RECRUITING
London
Site Number - 7313
RECRUITING
London
Site Number - 7300
RECRUITING
Manchester
Site Number - 7302
ACTIVE_NOT_RECRUITING
Newcastle Upon Tyne
Site Number - 7308
RECRUITING
Sheffield
Contact Information
Primary
Central Study Contact
clinicaltrials@immunovant.com
18007970414
Time Frame
Start Date: 2022-11-06
Estimated Completion Date: 2026-08
Participants
Target number of participants: 180
Treatments
Other: Observational cohort
Proptosis responders in feeder studies will enter in a non-treatment observational study
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Immunovant Sciences GmbH