Amgen’s Promising Phase 3 Study on Dazodalibep for Sjögren’s Syndrome

Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.

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 Symptom State (HZNP-DAZ-303)’. The study aims to assess the impact of dazodalibep on patient-reported symptoms and outcomes in individuals with Sjögren’s Syndrome, a condition characterized by dry eyes and mouth, among other symptoms. The significance of this study lies in its potential to improve the quality of life for patients with moderate-to-severe symptoms.

The intervention being tested is dazodalibep, administered via intravenous infusion. It is designed to alleviate symptoms of Sjögren’s Syndrome by targeting specific pathways involved in the disease’s progression.

The study follows a randomized, parallel assignment model with quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation. The primary purpose of the study is treatment-focused, aiming to establish the efficacy and safety of dazodalibep.

Key dates for the study include the start date on January 30, 2024, with the latest update submitted on August 20, 2025. These dates are crucial for tracking the study’s progress and anticipated completion.

From a market perspective, successful outcomes from this study could positively influence Amgen’s stock performance by enhancing its portfolio with a novel treatment for Sjögren’s Syndrome. This could also shift investor sentiment favorably, especially if dazodalibep demonstrates significant efficacy compared to existing treatments, potentially positioning Amgen ahead of competitors in this therapeutic area.

The study is currently ongoing, and further details are available on the ClinicalTrials portal.