Amgen’s Phase 2 Study on HZN-1116: A Potential Breakthrough for Sjögren’s Syndrome

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

Amgen Inc. is currently conducting a Phase 2 clinical study titled A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome. The study aims to assess the effectiveness and safety of HZN-1116, a drug intended to treat Sjögren’s syndrome, a chronic autoimmune condition. This study is significant as it targets two specific patient populations, focusing on those with varying degrees of disease activity and symptoms.

The intervention being tested is HZN-1116, administered subcutaneously. It is designed to alleviate symptoms associated with Sjögren’s syndrome. The study includes multiple dosage levels of HZN-1116 and a placebo for comparison.

This study follows a randomized, parallel assignment model with quadruple masking, meaning that the participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocations. The primary purpose of this study is treatment-focused, aiming to provide a new therapeutic option for Sjögren’s syndrome.

The study began on May 9, 2024, and is currently recruiting participants. The last update was submitted on July 24, 2025. These dates are crucial as they indicate the study’s progression and current status, which is essential for tracking its development and potential market entry.

The outcome of this study could significantly impact Amgen’s stock performance, as a successful treatment for Sjögren’s syndrome could open new revenue streams and strengthen its position in the pharmaceutical market. Investors should also consider the competitive landscape, as advancements in autoimmune disease treatments are a focus for many biotech companies.

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