Phase 3 OASIZ-301 Study of Dazodalibep in Sjögren's Disease Shows Statistically Significant and Clinically Meaningful Improvement in Systemic Disease Activity and Patient-Reported Dryness
New Long-Term UPLIZNA Data in IgG4-Related Disease and Real-World Evidence for KRYSTEXXA and TAVNEOS Further Highlight Amgen's Broad Portfolio and Commitment to People Living with Rare Diseases
THOUSAND OAKS, Calif., Oct. 27, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced plans to present new data across its portfolio, including in rare and other serious autoimmune diseases at the American College of Rheumatology (ACR) Convergence 2026.
Key presentations include:
Dazodalibep Significantly Reduces Systemic Disease Activity in Patients with Sjögren's Disease and Moderate-to-Severe Disease Activity: Results from the Phase 3 OASIZ-301 Trial
Late-Breaking Abstract #22, Wednesday, November 11, from 8:45â9:00 a.m. ET
Sjögren's disease is a systemic autoimmune disease that can affect 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.
Amgen will present late-breaking results from the Phase 3 OASIZ-301 study evaluating dazodalibep in adults living with Sjögren's disease and moderate-to-severe systemic disease activity. Dazodalibep is a CD40L antagonist that disrupts interactions between T cells, glandular epithelial cells, B cells and other antigen-presenting cells.
Patients entered the OASIZ-301 study with an average European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of 10.2. Results show that at Week 48 both dazodalibep dosing regimens (1,500 mg every four weeks and 3,000 mg every 12 weeks) demonstrated statistically significant and clinically meaningful reductions in systemic disease activity compared with placebo. Treatment effects were observed as early as four weeks. Disease activity scores improved by a least-squares mean change from baseline of -5.6 points in patients receiving dazodalibep every four weeks (difference vs placebo, â1.8; adjusted p0.001) and -5.2 points in those receiving treatment every 12 weeks (difference vs placebo, â1.4; adjusted p=0.010), compared with -3.8 points for placebo.
Additionally, dazodalibep every four weeks also demonstrated statistically significant and clinically meaningful improvements in the key secondary endpoint of patient-reported dryness compared with placebo. Patients reported greater reductions in dryness, as measured by both the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) dryness score (least-squares mean change from baseline, â2.50 vs. â1.33 for placebo; adjusted p0.001) and the Diary for Assessing Sjögren's Patient Reported Index (DASPRI) dryness score (least-squares mean change from baseline, â1.98 vs. â1.05 for placebo; adjusted p0.001). Treatment emergent adverse events (TEAEs), serious adverse events and TEAEs leading to discontinuation were observed at similar rates across treatment groups.
"For patients living with Sjögren's disease, systemic disease activity and symptoms can have a significant impact on their health and daily lives, yet treatment options remain limited," said Dr. Teresa K. Tarrant, MD, Associate Professor of Medicine, Duke University. "The rapid improvements in ESSDAI, as well as self-reported dryness, observed with dazodalibep are particularly encouraging. These findings represent meaningful progress in our understanding of how we may be able to better manage both the systemic and symptomatic manifestations of this complex disease."
Beyond dazodalibep, Amgen's scientific program at ACR Convergence 2026 will also include data from Phase 3 MITIGATE open-label extension describing the long-term safety profile and sustained efficacy of UPLIZNA in IgG4-RD. The company will also present real-world evidence from KRYSTEXXA® and TAVNEOS® in uncontrolled gout and ANCA-associated vasculitis, respectively.
"The data we're presenting at ACR demonstrate the breadth of Amgen's portfolio and pipeline across rare and other serious autoimmune diseases," said Paul Burton, M.D., Ph.D., senior vice president and chief medical officer at Amgen. "By advancing investigational therapies, generating long-term clinical evidence and building on our understanding of medicines in real-world settings, we're working to address significant unmet needs for patients living with some of the most complex and serious diseases."
Additional Amgen-sponsored abstracts:
UPLIZNA® (inebilizumab-cdon)
- Efficacy and Safety of Inebilizumab for the Treatment of IgG4-RD Across Age Subgroups: Analysis from the Open-label Period of the MITIGATE Trial
Abstract #2107; Poster Session C; Tuesday, November 10, 2026, 10:30 a.m.â12:30 p.m. ET
- Efficacy and Safety of Inebilizumab in Newly Diagnosed and Recurrent IgG4-RD Patients: Results From the Open-Label Period of the MITIGATE Study
Abstract #1129; Poster Session B; Monday, November 9, 2026, 10:30 a.m. â12:30 p.m. ET
- Long-Term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from the Year 1 Open-Label Period of a Phase 3 Trial (Encore)
Abstract #0177; Poster Session A; Sunday, November 8, 2026, 10:30 a.m. â12:30 p.m. ET
TAVNEOS® (avacopan)
- Effectiveness and Safety of Avacopan Added to Standard of Care (SOC) Versus SOC Alone in ANCA-associated Vasculitis
Abstract #2133; Poster Session C; Tuesday, November 10, 2026, 10:30 a.m.â12:30 p.m. ET
- Glucocorticoid-Associated Conditions in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis With Prolonged Moderate-to-High Dose Glucocorticoid Use (Encore)
Abstract #1156; Poster Session B; Monday, November 9, 2026, 10:30 a.m. â12:30 p.m. ET
KRYSTEXXA® (pegloticase)
- Induction and Maintenance of Gout Remission During Intensive Urate-Lowering with Pegloticase: Post Hoc Analysis of a 2.5 Year Open-Label Extension Study
Abstract #0714; Poster Session A; Sunday, November 8, 2026, 10:30 a.m.â12:30 p.m. ET
- Real-World Attainment and Durability of Gout Remission Following Pegloticase Initiation in a U.S. Practice Based Rheumatology Network
Abstract #0853; Poster Session A; Sunday, November 8, 2026, 10:30 a.m.â12:30 p.m. ET
- Induction of Clinical Remission in Patients with Uncontrolled Gout Treated with Pegloticase and Immunomodulation: Experience in Two Community Rheumatology Practices
Abstract #2648; Poster Session C; Tuesday, November 10, 2026, 10:30 a.m.â12:30 p.m. ET
- The Pattern and Severity of Gout Flares Prior to and During Pegloticase Treatment in the MIRROR and AGILE Clinical Trials
Abstract #2657; Poster Session C; Tuesday, November 10, 2026, 10:30 a.m.â12:30 p.m. ET
- Real-World Use of Immunomodulation Co-therapy Among Pegloticase New Users
Abstract #2653; Poster Session C; Tuesday, November 10, 2026, 10:30 a.m.â12:30 p.m. ET
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, glandular epithelial 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. The OASIZ 303 study is expected to complete in Q4 2026.
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 UPLIZNA® (inebilizumab-cdon)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects in IgG4-RD is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.
About TAVNEOS® (avacopan)
TAVNEOS is an orally administered small molecule indicated as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis (GPA/MPA). It is a selective complement 5a receptor (C5aR) antagonist that targets inflammation by blocking the activity of C5a, a key driver of neutrophil activation.