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argenx Provides Update on UplighTED Studies of Efgartigimod SC in Thyroid Eye Disease
Globenewswireยท 2025-12-15 06:00
Core Viewpoint - argenx SE has announced the discontinuation of the Phase 3 UplighTED studies evaluating efgartigimod for moderate to severe thyroid eye disease (TED) based on an Independent Data Monitoring Committee's recommendation due to futility [1][2] Group 1: Study Discontinuation - The Phase 3 UplighTED studies were halted after an interim analysis indicated that the trials did not meet the desired outcomes [2][3] - The decision reflects a responsible evaluation of the study's future likelihood of success, emphasizing the company's commitment to disciplined resource management [3] Group 2: Study Design and Objectives - The UplighTED studies were randomized, double-masked, placebo-controlled trials designed to assess the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of efgartigimod in adults with active, moderate-to-severe TED [4] - The primary endpoint was the percentage of participants who were proptosis responders at week 24, with key secondary endpoints including changes in proptosis measurement and quality of life scores [4] Group 3: Background on Thyroid Eye Disease - Thyroid Eye Disease (TED) is an autoimmune condition associated with Graves' disease and characterized by symptoms such as proptosis, diplopia, and potential vision loss, significantly impacting patient quality of life [5] Group 4: About Efgartigimod - Efgartigimod is a human IgG1 antibody fragment that reduces circulating IgG autoantibodies and is the first approved FcRn blocker for various autoimmune diseases [6]