安进dazodalibep治疗中重度系统性干燥综合征III期OASIZ 301达主要终点
AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR DAZODALIBEP IN MODERATE-TO-SEVERE SYSTEMIC SJÖGREN'S DISEASE
安进公布III期OASIZ 301顶线结果：dazodalibep在中重度系统性干燥综合征成人中第48周ESSDAI较基线改善达统计学显著且具临床意义，第4周即见改善并持续至48周。研究n约621，ESSDAI≥5入组；常见不良事件为鼻咽炎、尿路感染、高血压和输注相关反应。
关注CD40L靶点在干燥综合征的首个III期读出，及OASIZ 303症状人群数据对适应症广度的影响。
Dazodalibep Demonstrated Statistically Significant and Clinically Meaningful Improvement in Systemic Disease Activity
Results Support the Potential for a New, Highly Differentiated Treatment Option for People Living With a Debilitating Autoimmune Disease
, /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjögren's disease and moderate-to-severe systemic disease activity.
The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 48, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). Notably, improvements in ESSDAI were observed as early as Week 4 with treatment with dazodalibep, which were sustained through Week 48 of the study. ESSDAI is a validated clinical tool used to assess systemic disease activity across organ systems in patients with Sjögren's disease.
Sjögren's disease is a systemic autoimmune disease that affects the entire body. Along with symptoms of extensive dryness, other serious manifestations may include profound fatigue, chronic pain, major organ involvement, neuropathy, and an increased risk of lymphoma. There are currently no FDA-approved medicines for Sjögren's disease.
"The results mark an important step forward for people living with Sjögren's disease, a condition with significant unmet need and no approved systemic treatment options," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "The rapid and sustained improvement observed in systemic disease activity reinforces our confidence in dazodalibep and the broader Phase 3 program as we work to deliver a new, highly differentiated option for people living with this debilitating autoimmune disease."
The most common adverse events (>/= 5% incidence, reported at a higher rate in dazodalibep compared with placebo) were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, and were generally mild to moderate in nature. Discontinuations due to adverse events occurred at a low rate and were balanced across treatment groups. No imbalance in the incidence of thromboembolic events or opportunistic infections was observed across treatment arms.
"Patients with Sjogren's disease contend with debilitating symptoms and systemic manifestations for which no approved disease-modifying therapy exists," said Ghaith Noaiseh, M.D., Associate Professor of Medicine, Division of Allergy, Clinical Immunology and Rheumatology at the University of Kansas Medical Center, and lead investigator of the study. "These topline results provide further support for dazodalibep as an emerging treatment for improving systemic disease activity and represent an important advance for the field."
"Sjögren's disease is a complex and heterogeneous autoimmune disease, and no two people experience it in exactly the same way. It can be relentless, creating a real burden for people living with the disease and affecting their quality of life," said Janet E. Church, President and Chief Executive Officer, Sjögren's Foundation. "The Sjögren's Foundation welcomes continued progress in research that expands the possibilities for people living with Sjögren's disease and moves us toward a future with more treatment options and better care."
The company plans to present detailed data from the OASIZ 301 study at an upcoming medical meeting.
The Phase 3 OASIZ 303 study of dazodalibep in moderate-to-severe symptomatic Sjögren's disease is expected to complete in Q4 2026.
补充资料（5 节）药物、疾病与研究背景 · 法律与声明
药物、疾病与研究背景
About Dazodalibep
Dazodalibep is a potential first-in-class CD40L antagonist fusion protein that is designed to target immune activation by disrupting interactions between T cells, B cells and other antigen-presenting cells. Dazodalibep is being studied in two Sjögren's disease patient groups: those with moderate-to-severe systemic disease and those with high symptom burden and low systemic disease who suffer from dryness, fatigue, and/or pain that profoundly impact daily life.
About OASIZ 301 and the Dazodalibep Development Program
OASIZ 301 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of dazodalibep in patients with Sjögren's disease with moderate-to-severe systemic disease activity (ESSDAI ≥ 5) (n=approximately 621). The primary endpoint of the study is change from baseline in ESSDAI score at Week 48.
Key secondary endpoints evaluated dryness, tender and swollen joints, fatigue, and ESSDAI[5] response, defined as a decrease of at least 5 points from baseline.
Additionally, Amgen is conducting OASIZ 303, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of dazodalibep in patients with high symptom burden with low systemic Sjögren's disease activity. Amgen is also conducting OASIZ 304, an open-label, long-term extension study evaluating the long-term safety and tolerability of dazodalibep in eligible participants from OASIZ 301 and OASIZ 303.
About Sjögren's Disease
Sjögren's disease (SjD) is a heterogeneous autoimmune disease, where patients can experience persistent dryness, fatigue, and pain, often alongside systemic involvement that can be progressive. Although SjD is the second most common autoimmune rheumatic disease, it remains widely underrecognized, with the full extent of its systemic severity and debilitating symptomatic impact on patients' lives often underestimated. Despite this burden, there are currently no approved therapies for SjD, and many patients continue to experience persistent systemic disease activity and debilitating symptoms.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.
More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions.
Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.
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