Thyroid Eye Disease Clinical Trial
Official title:
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)
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.
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | June 2025 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Site Number - 4671 | Brugge | |
| Belgium | Site Number - 4670 | Gent | |
| Hungary | Site Number - 7550 | Budapest | |
| Latvia | Site Number - 9301 | Ogre | |
| Latvia | Site Number - 9302 | Ventspils | |
| Spain | Site Number - 3602 | Barcelona | Catalonia |
| Spain | Site Number - 3606 | Sevilla | |
| Spain | Site Number - 3603 | Valencia | |
| United States | Site Number - 1520 | Glendora | California |
| United States | Site Number - 1513 | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Immunovant Sciences GmbH |
United States, Belgium, Hungary, Latvia, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies | Up to Week 24 | ||
| Secondary | Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies | At Week 24 | ||
| Secondary | Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies | At Week 24 |
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