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Active (not recruiting) Phase 3 NCT05517447

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Phase 3 – large-scale trial before approval
Conditions: Thyroid Eye Disease

Sponsor: Immunovant Sciences GmbH

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 14
Australia (1)
Site Number - 7565
Sydney
Belgium (1)
Site Number - 4671
Bruges
Georgia (1)
Site Number - 3454
Tbilisi
Hungary (1)
Site Number - 7550
Budapest
Israel (1)
Site Number - 4760
Ramat Gan , Tel Aviv
Italy (1)
Site Number - 6207
Catania
Latvia (1)
Site Number - 9301
Ogre
New Zealand (1)
Site Number - 7570
Christchurch
Poland (1)
Site Number - 3107
Gliwice , Silesian Voivodeship
Puerto Rico (1)
Site Number - 1990
San Juan
Slovakia (1)
Site Number - 9200
Bratislava
Spain (1)
Site Number - 3602
Barcelona , Catalonia
United Kingdom (1)
Site Number - 7305
Guildford
United States (1)
Site Number - 1520
Glendora , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.11.2022
Completion date
01.08.2026
Registry ID
NCT05517447
Source
anzctr
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