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)
Primary Objective
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)
Description
Study IMVT-1401-3203 is a 2-cohort extension study for eligible participants completing the Week 24 visit on the feeder studies, IMVT-1401-3201 or IMVT-1401-3202. Participants will be assessed as proptosis responders or non-responders at Week 24 in the feeder studies. Based upon this assessment, participants will be assigned as follows: - An Observational Cohort, comprised of participants classified as proptosis responders in either IMVT-1401-3201 or IMVT-1401-3202, who will enter a 24- week non-treatment observational study during which the durability of their proptosis response will be assessed. - A Treatment Cohort, comprised of participants classified as proptosis non responders in either IMVT-1401-3201 or IMVT-1401-3202, who will enter an open-label, non-placebo-controlled study of batoclimab as an initial or extended treatment of batoclimab of 680 mg subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks.
Details
Locations
University of Colorado Hospital
Principal Investigator
Prem Subramanian
Study ID
Protocol Number: 22-2037
Categories
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