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 Symptom State (HZNP-DAZ-303)’. The study aims to assess the impact of dazodalibep on symptoms reported by patients with Sjögren’s Syndrome (SS), focusing on both efficacy and safety. This research is significant as it targets a condition with limited treatment options, potentially offering new hope for patients.
The study is testing the drug dazodalibep, administered via intravenous infusion, against a placebo. Dazodalibep is designed to alleviate symptoms in patients with moderate-to-severe SS, aiming to improve their quality of life.
This interventional study is randomized and follows a parallel assignment model. It employs quadruple masking, meaning the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocations. The primary purpose of the study is treatment-focused.
The study began on April 8, 2024, with the latest update submitted on August 20, 2025. These dates are crucial as they indicate the study’s progression and ongoing status, which is currently recruiting participants.
From a market perspective, the successful development of dazodalibep could enhance Amgen’s stock performance, as it addresses an unmet need in the treatment of Sjögren’s Syndrome. This could also influence investor sentiment positively, especially in comparison to competitors who may not have similar advancements in this therapeutic area.
The study is ongoing, with further details available on the ClinicalTrials portal.