Argenx SE (NASDAQ:ARGX), the global immunology company, announced on December 15, 2025, the discontinuation of its Phase 3 UplighTED studies evaluating efgartigimod SC (subcutaneous injection) in adults with moderate-to-severe Thyroid Eye Disease (TED).
The decision follows a recommendation from an Independent Data Monitoring Committee (IDMC), which reviewed unblinded data from patients who completed 24 weeks of the study and determined that the trial should be stopped for futility.
Futility, in this context, signifies that the drug was unlikely to meet its primary efficacy endpoint even if the trial were to continue to completion.
The primary endpoint for the UplighTED studies was the percentage of participants who were proptosis responders at Week 24.
Despite the clinical efficacy setback, the company emphasized that efgartigimod SC demonstrated a favorable safety and tolerability profile, with no new safety signals identified in the interim analysis.
Efgartigimod, which is approved as VYVGART and VYVGART SC for generalized myasthenia gravis (gMG) and other autoimmune conditions, is a first-in-class FcRn blocker.
It is designed to selectively reduce circulating Immunoglobulin G (IgG) antibodies, including the pathogenic autoantibodies believed to drive TED.
Argenx confirmed it will now proceed with closing out the UplighTED studies, locking the databases, and performing a comprehensive analysis of the accumulated data.
The detailed findings are expected to be shared at a future medical meeting to inform the broader understanding of TED and the role of FcRn antagonism in the disease.