Argenx ((ARGX)) announced an update on their ongoing clinical study.
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Argenx is conducting a Phase 3 clinical study titled ‘A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy.’ The study aims to evaluate the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with active idiopathic inflammatory myopathy (IIM), a group of rare autoimmune diseases. This research is significant as it could lead to new treatment options for patients with these challenging conditions.
The intervention being tested is a biological treatment named EFG PH20 SC. It is a subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer, intended to improve the treatment of IIM by enhancing drug delivery and efficacy.
This interventional study follows a single-group assignment model without masking, meaning all participants receive the experimental treatment, and both researchers and participants know the treatment being administered. The primary goal is to assess the treatment’s safety and effectiveness over the long term.
The study began on July 28, 2023, and is currently enrolling participants by invitation. The primary completion and estimated study completion dates are set for August 27, 2025, which marks the timeline for collecting and analyzing primary data. The last update was also on August 27, 2025, indicating ongoing progress and adjustments in the study.
This study update could positively influence Argenx’s stock performance and investor sentiment, as successful results may enhance the company’s competitive position in the autoimmune disease treatment market. Investors should monitor this study’s progress, as it could impact market dynamics and Argenx’s valuation.
The study is ongoing, and further details are available on the ClinicalTrials portal.