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 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-severe Systemic Disease Activity.’ The study aims to assess the impact of dazodalibep on systemic manifestations of Sjögren’s Syndrome (SS) and its effect on patient-reported outcomes, alongside evaluating the drug’s safety and tolerability.
The study is testing an intravenous drug named Dazodalibep, which is designed to treat moderate-to-severe systemic disease activity in Sjögren’s Syndrome. Participants receive either one of two doses of Dazodalibep or a placebo.
This interventional study follows a randomized, parallel assignment model with quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are unaware of the treatment allocations. The primary goal is treatment-focused.
The study began on January 24, 2024, and its primary completion is yet to be announced. The latest update was submitted on August 5, 2025. These dates are crucial for tracking the study’s progress and potential market entry.
The ongoing study could influence Amgen’s stock performance positively, especially if the results demonstrate significant efficacy and safety, potentially boosting investor confidence. It also positions Amgen competitively within the pharmaceutical industry, particularly in the autoimmune disease treatment market.
As of now, the study is active but not recruiting, with further details available on the ClinicalTrials portal.