Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

Novartis reported that ianalumab met the primary endpoint of improving disease activity in two Phase 3 trials, NEPTUNUS‑1 and NEPTUNUS‑2, versus placebo, using the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) at 52 weeks.5

The company said both studies showed ianalumab was well tolerated with a favorable safety profile; detailed data will be presented at a future medical conference.5

According to Clinical Trials Arena, NEPTUNUS‑1 evaluated monthly intravenous ianalumab, while NEPTUNUS‑2 tested subcutaneous dosing monthly or every three months, enrolling a combined 749 patients with Sjögren’s disease.1

Novartis plans to submit approval applications globally based on these Phase 3 results, positioning ianalumab to potentially become the first targeted treatment for Sjögren’s disease if approved.1

Novartis characterized the results as the first global Phase 3 trials to show a statistically significant reduction in Sjögren’s disease activity, a milestone in a field where many programs have failed.5

Context:
Novartis previously discontinued its anti‑CD40 antibody iscalimab in Sjögren’s (January 2025) and halted ianalumab development in hidradenitis suppurativa after a negative Phase 2b readout (July 2025).1

Sources:

1. https://www.clinicaltrialsarena.com/news/novartis-mab-could-become-first-sjogrens-disease-drug-after-phase-iii-success/

5. https://www.fiercebiotech.com/biotech/novartis-scores-double-phase-3-win-sjogrens-syndrome-succeeding-where-others-failed