Amgen’s dazodalibep met the Phase 3 OASIZ 301 primary endpoint, reducing systemic disease activity in adults with moderate-to-severe Sjögren’s disease.
Written By: Siddhi Bhadekar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
Amgen reported positive topline results from the Phase 3 OASIZ 301 study (NCT06104124), in which dazodalibep reduced systemic disease activity in adults with moderate-to-severe Sjögren’s disease. The study met its primary endpoint, supporting further development of dazodalibep as a potential treatment for the autoimmune disease.
Phase 3 Study Shows Sustained Improvement in Systemic Disease Activity
OASIZ 301 met its primary endpoint, showing a statistically significant and clinically meaningful improvement in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 48 compared with placebo.
ESSDAI is a validated measure of systemic disease activity across multiple organ systems affected by Sjögren’s disease. Amgen reported that the improvement with dazodalibep emerged as early as Week 4 and persisted through Week 48.
The randomized, double-blind, placebo-controlled Phase 3 trial enrolled approximately 621 adults with moderate-to-severe systemic disease activity, defined by an ESSDAI score of at least 5. The primary endpoint was the change from baseline in ESSDAI at Week 48.
Key secondary measures included dryness, tender and swollen joints, fatigue, and ESSDAI response, defined as a reduction of at least 5 points from baseline. Amgen has not yet disclosed the detailed numerical efficacy results or statistical values and plans to present the full dataset at an upcoming medical meeting.
CD40L Blockade Targets Immune Cell Interactions
Dazodalibep is a potential first-in-class CD40L antagonist fusion protein that blocks CD40L-mediated interactions between T cells, B cells and antigen-presenting cells.
These immune-cell interactions contribute to B-cell activation and broader autoimmune signaling. By inhibiting the CD40L pathway, dazodalibep is being evaluated for its ability to reduce systemic immune activity in Sjögren’s disease.
Sjögren’s disease can cause persistent dryness, fatigue and pain, but systemic disease may also affect organs and involve manifestations such as neuropathy. The disease is also associated with an increased risk of lymphoma. Despite its systemic burden, no therapies currently have FDA approval specifically for Sjögren’s disease.
Safety Profile Remained Consistent with the Study
The most common adverse events occurring at a higher rate with dazodalibep than placebo were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions. These events were generally mild to moderate.
Discontinuations because of adverse events were low and balanced between treatment groups. Amgen also reported no imbalance in thromboembolic events or opportunistic infections across the treatment arms.
The safety findings remain topline and could be further characterized when the complete OASIZ 301 dataset is presented.
Broader Phase 3 Program Continues
Amgen is evaluating dazodalibep across two distinct Sjögren’s disease populations. OASIZ 301 focuses on patients with moderate-to-severe systemic disease activity, while OASIZ 303 is studying patients with high symptom burden but low systemic disease activity, including prominent dryness, fatigue or pain.
OASIZ 303 is expected to complete in the fourth quarter of 2026. The company is also conducting OASIZ 304, an open-label long-term extension study assessing the safety and tolerability of dazodalibep in eligible participants from OASIZ 301 and OASIZ 303 (NCT06245408).
The OASIZ 301 results provide the first topline Phase 3 evidence from the program showing sustained improvement in a validated measure of systemic Sjögren’s disease activity. Detailed efficacy and safety data from the study will determine how the findings translate across individual disease domains and inform the next stages of clinical development.
Reference
Amgen Announces Positive Topline Phase 3 Results for Dazodalibep in Moderate-To-Severe Systemic Sjögren’s Disease, Amgen, 22 September 2026
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome (SS) With Moderate-to-severe Systemic Disease Activity, ClinicalTrials.gov ID NCT06104124
About the Writer
Siddhi Rajendra Bhadekar (Linkedin) is an M.Pharm professional with expertise in medical and scientific writing, literature review, publication writing, and evidence synthesis, supported by four peer-reviewed publications.
She brings working knowledge of ICH-GCP, MedDRA, pharmacovigilance, ADR/AE reporting, clinical data management, and regulatory documentation.
With experience across pharmaceutical R&D, Quality Control, and Quality Assurance, she combines scientific research skills with strong attention to accuracy and detail.
Her background in manuscript development, publication planning, and scientific communication enables her to translate complex healthcare information into clear, reliable content.