Ianalumab Shows Mixed Results in Sjögren's Disease Trials
New phase III data reveals significant clinical improvement but misses key secondary endpoints for the Novartis drug.
Updated on Oct. 21, 2026 in Diabetes
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Researchers have published phase III trial results for ianalumab in patients with Sjögren's disease. The study demonstrated statistically significant improvement in primary clinical scores but failed to show a difference from placebo in secondary outcomes.
Why it matters
The study sought to evaluate if the B-cell activating factor inhibitor could provide a breakthrough treatment for Sjögren's disease. The mixed results highlight the complexity of addressing the condition's wide range of systemic symptoms.
The NEPTUNUS-1 and NEPTUNUS-2 trials enrolled 779 total patients to measure efficacy against a standard P value of 0.05. Results showed no difference from placebo for the 3-month dosing arm compared to the primary monthly treatment group.
The players
Novartis
This Swiss multinational pharmaceutical corporation specializes in developing and manufacturing innovative medicines for a range of medical conditions.
Johns Hopkins University
This private research university in Baltimore is a major hub for clinical trials and medical discovery.
University of Turin
This historic public research institution in Italy contributes to international clinical research efforts.
The details
Patients received ianalumab via monthly injections, with the NEPTUNUS-2 trial testing an additional arm using 3-month intervals. While primary endpoint changes in ESSDAI scores were significant, key secondary measures related to salivation and dryness remained unchanged.
Timeline
May 2026: The THALASSA trial was first listed.
Q3 2026: Target window for Novartis marketing applications.
August 2029: Estimated primary completion of the THALASSA trial.
The Big Picture
The THALASSA trial extends existing research into B-cell inhibitors by expanding the patient cohort to 570 participants.
Patients currently managing Sjögren's disease may need to wait for further trial data before this therapy becomes a viable treatment option. There is no current change to standard care practices while the drug's efficacy profile remains under investigation.
The takeaway
While these results demonstrate progress for a specific clinical endpoint, the lack of improvement in secondary dryness symptoms suggests a long road ahead for comprehensive treatment. Researchers and patients are now looking toward future trials to clarify the drug's full therapeutic potential.
What happens next
Novartis continues to move forward with the THALASSA trial, which has an estimated primary completion date of August 2029.
Further reading
For more on the latest research in the field, explore the Diabetes section.
Source note: This article includes information reported by MedPage Today.
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