Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
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Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV).' The study aims to assess the efficacy of avacopan in treating children with AAV, a rare autoimmune disease, highlighting its potential significance in pediatric care.
The intervention being tested is avacopan, an oral drug administered twice daily, designed to treat AAV by reducing inflammation and autoimmunity. It is combined with either rituximab or a cyclophosphamide-containing regimen.
This study follows a non-randomized, single-group assignment model with no masking, focusing on treatment as its primary purpose. Participants will receive avacopan for 52 weeks to evaluate its effects.
The study began on October 22, 2024, with an estimated primary completion date yet to be announced. The latest update was submitted on August 6, 2025, indicating ongoing recruitment and progress.
The study’s outcome could significantly influence Amgen’s market position, potentially boosting investor confidence and stock performance if results demonstrate avacopan’s efficacy. This development is particularly relevant in the competitive pharmaceutical landscape focused on innovative treatments for rare diseases.
The study is currently ongoing, with further details available on the ClinicalTrials portal.