Phase III Study to Assess Safety and Effectiveness of IBI311 in Adults with Inactive Thyroid Eye Disease

What this Trial Is About

Researchers are evaluating the efficacy and safety of IBI311, also known as Teprotumumab N01 injection, in adults with inactive thyroid eye disease TED. This multicenter, randomized, double-masked, placebo-controlled Phase III clinical trial involves approximately 111 participants to assess how well IBI311 works compared to a placebo. The study aims to better understand treatment effects on eye protrusion and other disease symptoms over a long follow-up period. Participants will be randomly assigned to receive either IBI311 or a placebo in a 21 ratio. The study has two parts lasting about 64 weeks in total. Part 1 includes a screening and treatment phase lasting around 28 weeks with masked treatment. Part 2 is an open follow-up or treatment period lasting up to 36 weeks. The treatments are given by injection, and participants will be monitored closely throughout both parts. During the trial, participants will undergo regular assessments including eye examinations measuring proptosis eye protrusion, diplopia double vision, and clinical activity scores. Safety and tolerability of IBI311 will be evaluated through laboratory tests, imaging, and questionnaires such as the Graves Ophthalmopathy Quality of Life survey. The primary outcome is the proptosis response rate at 24 weeks. Participants will be followed for safety and disease activity for up to about one year after treatment.

A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease