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)

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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
Age

Adult

Eligibility

The study population will consist of participants 18 years or older who completed the feeder studies.

Locations

University of Colorado Hospital

Principal Investigator
Photograph of Prem Subramanian

Prem Subramanian

Study ID

Protocol Number: 22-2037

Categories

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