Phase 3 Evaluation of Linsitinib for Adults With Moderate to Severe Active Thyroid Eye Disease

What this Trial Is About

Researchers are evaluating the effects of linsitinib in adults with moderate to severe active Thyroid Eye Disease TED. This Phase 3 study aims to assess the efficacy, safety, and tolerability of linsitinib compared to placebo in improving symptoms of TED, a condition often linked to Graves Disease or autoimmune Hashimotos thyroiditis. The study focuses on participants who have active TED with significant eye symptoms impacting daily life but not sight-threatening. Participants are randomly assigned to receive either linsitinib 150 mg twice daily or a placebo for 24 weeks. Those who do not respond or relapse in proptosis eye bulging may receive linsitinib for an additional 24 weeks in an open-label extension phase. The study uses a quadruple-masked design to evaluate the effects of linsitinib versus placebo on eye symptoms and quality of life. During the study, participants undergo assessments to measure proptosis response, changes in eye symptoms, and quality of life questionnaires over 24 weeks. Researchers monitor thyroid function, clinical activity scores, and safety throughout treatment. The primary outcome is the percentage of participants who respond in proptosis at Week 24. Participants are carefully observed for any adverse effects, with the study lasting until June 2030.

Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)