First-Ever Phase III Trials Deliver Meaningful Results for Sjögren's Disease with Ianalumab
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For the first time ever, two Phase III clinical trials have shown a statistically significant reduction in Sjögren's disease activity. The drug ianalumab, which depletes B cells and blocks BAFF-R signaling, met its primary endpoint in both the NEPTUNUS-1 and NEPTUNUS-2 trials, with patients also reporting meaningful improvements in dryness, pain, and fatigue. If approved, it would be the first disease-modifying therapy specifically indicated for Sjögren's disease.
Abstract
Novartis announced that both NEPTUNUS-1 and NEPTUNUS-2 Phase III clinical trials of ianalumab met their primary endpoint in patients with primary Sjögren's disease. Ianalumab is a fully human monoclonal antibody with a dual mechanism of action that depletes B cells and inhibits their activation and survival via BAFF-R blockade. Ianalumab 300 mg administered monthly demonstrated clinically meaningful improvement in disease activity as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) versus placebo.
Secondary endpoints showed numerical improvement in dryness, pain, and fatigue in patient-reported outcomes. Stimulated salivary flow rate and oral dryness also improved versus placebo. Ianalumab had previously received FDA Breakthrough Therapy designation for Sjögren's disease. Novartis plans to initiate regulatory submissions globally beginning in early 2026. These trials represent the first Phase III program to demonstrate statistically significant and clinically meaningful reduction in disease activity in Sjögren's disease.