Extension Study of Two Oral Linsitinib Doses in Adults With Active, Moderate to Severe Thyroid Eye Disease

What this Trial Is About

Researchers are evaluating the continued effects of linsitinib in adults with active, moderate to severe Thyroid Eye Disease TED who participated in a previous study VGN-TED-301. This extension study focuses on participants who either did not respond to treatment by Week 24 or who relapsed during the follow-up period. The goal is to further assess the drugs effectiveness, safety, and how the body processes and responds to it over time. Participants will receive one of two doses of linsitinib, taken twice daily by mouth. The study is randomized and double-blind, meaning neither participants nor researchers know which dose is given. The treatment period lasts 24 weeks, during which participants are monitored to evaluate changes in eye protrusion proptosis and other disease symptoms. This study continues from the previous trial without introducing new treatment types. Throughout the study, participants will undergo evaluations of their eye condition, including measuring proptosis and overall disease activity using standardized assessments. Quality of life related to Graves Ophthalmopathy will also be measured through questionnaires. Safety and drug effects will be closely monitored. The study is expected to last at least 24 weeks, focusing on how participants respond to linsitinib over this period.

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)