Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Sponsored by Immunovant Sciences GmbH
About this trial
Last updated 2 years ago
Study ID
IMVT-1401-3203
Status
Not yet recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 14 days ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
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
1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.