AMGEN TO PRESENT NEW DATA ACROSS RARE AND OTHER SERIOUS AUTOIMMUNE DISEASES AT ACR CONVERGENCE 2026
Amgen will present late-breaking Phase 3 OASIZ-301 data at ACR Convergence 2026 showing dazodalibep significantly reduced systemic disease activity in Sjögren's patients, with both dosing regimens beating placebo (ESSDAI least-squares mean change -5.6 and -5.2 vs -3.8; adjusted p<0.001 and p=0.010). The every-four-weeks regimen also hit the key secondary endpoint of patient-reported dryness (ESSPRI -2.50 vs -1.33 placebo), with adverse event rates similar across arms. There are currently no FDA-approved therapies for Sjögren's disease, making dazodalibep a potential first-in-class opportunity.
Key figures
- Drug Name
- dazodalibep
- Phase Of Trial
- Phase 3
- Trial
- OASIZ-301
- Indication
- Sjögren's disease
- Trial size
- approximately 621
- P value q4w
- adjusted p<0.001
- Next readout
- OASIZ 303 expected to complete Q4 2026
- P value q12w
- adjusted p=0.010
- Essdai placebo
- -3.8
- Primary endpoint
- change from baseline in ESSDAI score at Week 48
- Essdai ls mean change q4w
- -5.6
- Essdai ls mean change q12w
- -5.2
AI analysis
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