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)
- Sponsor: Immunovant Sciences GmbH
- Principal Investigator: Suzanne Van Landingham, MD
- Study Coordinator: Kris Dietzman
Study Objective:
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.
Study Design:
This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202).
Inclusion Criteria:
For all participants:
- 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
Exclusion Criteria:
- In the Investigator’s judgement, the benefits of entry in the study do not outweigh the risk.
Contact Kris Dietzman with questions, (608) 263-9035
For more information about this study, visit clinicaltrials.gov: Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease – Full Text View – ClinicalTrials.gov