EUCTR2022-002839-66-HUActive, not recruitingPhase 1
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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Immunovant Sciences, GmbH
- Enrollment
- 180
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 162
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
Exclusion Criteria
- •For all participants:
- •1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
Investigators
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