Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
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Amgen Inc. is conducting a Phase 4 clinical trial titled ‘A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis.’ The study aims to assess the long-term safety of avacopan, a drug intended for patients with ANCA-associated vasculitis, a serious autoimmune disease affecting blood vessels.
The trial is testing avacopan, an oral medication, in combination with standard immunosuppressive therapy. The study involves three groups: one receiving avacopan for five years, another receiving avacopan for one year followed by a placebo, and a third receiving a placebo for five years, all alongside standard care.
This interventional study is randomized with a parallel assignment model and double masking for participants and investigators. Its primary purpose is treatment-focused, aiming to establish avacopan’s safety over a long duration.
The study began on February 7, 2024, with a primary completion date yet to be announced. The latest update was submitted on July 16, 2025, indicating ongoing recruitment and progress.
For investors, this study could influence Amgen’s stock performance, as successful results may enhance market confidence and competitiveness in the autoimmune treatment sector. Avacopan’s potential approval could position Amgen favorably against competitors in the vasculitis treatment market.
The study is currently ongoing, with further details available on the ClinicalTrials portal.