TL;DR
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Two phase III trials of ianalumab met their primary disease-activity endpoint, but the average benefit over placebo was small and key symptom outcomes did not show clear differences. Novartis has started a third phase III trial, while it remains unclear whether the company submitted the marketing applications it had previously planned.
Full results from two phase III trials of Novartis’ ianalumab in Sjögren’s disease show a statistically significant but small improvement in disease activity compared with placebo, while several key symptom measures did not show clear benefits. The findings leave the drug’s path toward approval uncertain; Novartis has begun a third phase III trial, and it has not confirmed whether it submitted the marketing applications it had previously planned.
The NEPTUNUS-1 and NEPTUNUS-2 trials enrolled 779 people in total and compared ianalumab with placebo. Their primary measure was change in the EULAR Sjögren’s Syndrome Disease Activity Index, or ESSDAI, after a year. Monthly ianalumab met that endpoint in both studies, but the average difference from placebo was 1.3 points in NEPTUNUS-1 and 1.0 point in NEPTUNUS-2. The first result was close to the conventional statistical cutoff, with P=0.0496.
Participants receiving monthly ianalumab had average ESSDAI reductions of 6.4 and 6.5 points in the two trials, compared with 5.1 and 5.5 points among placebo recipients. Combining the monthly-dose results produced a P value of 0.003, but the pooled average difference remained a little over one ESSDAI point. The separate dosing arm in NEPTUNUS-2, which used treatment every three months, did not differ from placebo on the primary measure.
The published results also found no clear advantage on several secondary measures, including symptoms and patient-reported outcomes. The proportion of participants whose ESSDAI score fell by at least five points was numerically higher with monthly ianalumab, but the reported confidence intervals overlapped. Measures of dryness, fatigue and other symptoms likewise showed mostly numerical trends rather than definite differences. Investigators reported that adverse effects were not concerning.
A Small Gain With Symptom Questions
The results matter because Sjögren’s disease has no approved targeted therapies, and ianalumab is intended to interfere with B-cell activating factor, a protein involved in B-cell activity. A treatment that reliably reduces disease activity or eases patients’ symptoms could address an unmet need. But the gap between a statistically significant primary result and the less consistent secondary findings makes the clinical value harder to judge.
In an editorial accompanying the study, Simone Negrini of the University of Turin said the similar estimates across the two trials make a drug effect more credible than a single positive study. He also cautioned that the effect was small and that many other outcomes showed no definite benefit. The findings therefore support further evaluation, but do not by themselves establish how useful the medicine would be to patients or whether the evidence will be sufficient for regulators.
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How the NEPTUNUS Trials Were Designed
The two randomized trials had similar designs but different enrollment. NEPTUNUS-1 enrolled 275 patients, assigning them to monthly ianalumab or placebo. NEPTUNUS-2 enrolled 504 and included those two groups plus an arm using treatment every three months. Average ESSDAI scores at the start were about 12.
Some results were presented at the American College of Rheumatology’s annual meeting before the full findings appeared in the New England Journal of Medicine. The primary endpoint had been met in both trials, and pooled results strengthened the statistical signal. The full publication adds detail on secondary outcomes, including salivary flow, where the results did not establish a consistent benefit over placebo.
Novartis had previously said it planned to submit marketing applications early in 2026. Its February annual report shifted that timeline to the third quarter. That quarter has ended, but the company had not publicly clarified whether it filed, according to the source report.
“The effect was small and there were no significant differences in key secondary outcomes.”
— Thomas Grader-Beck, MD, of Johns Hopkins University, and colleagues
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Regulatory Plans Still Unconfirmed
Novartis has not clarified whether it submitted the marketing applications it had planned for the third quarter of 2026. The available report also does not establish what regulatory agencies might conclude from the two trials or whether the published evidence would meet their requirements.
The clinical importance of the modest ESSDAI differences remains uncertain, particularly because improvements in salivation and several patient-reported measures were not clearly established. The studies reported that safety was not concerning, but the available material does not provide enough detail here to assess individual risks or how safety will be characterized across a larger treatment population.
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THALASSA Will Test Another Group
The next major study is THALASSA, a placebo-controlled phase III trial in people with Sjögren’s disease and a high symptom burden. It was first listed in May 2026, with a planned enrollment of 570 participants and estimated primary completion in August 2029. Its results may add evidence about whether ianalumab benefits a more symptom-burdened group, but they will not be available soon.
In the meantime, the immediate developments to watch are whether Novartis confirms a regulatory filing and how the company frames the two published trials. The exact submission status, any regulator response and the results of THALASSA remain outstanding.
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Key Questions
Did ianalumab meet the primary endpoint in the trials?
Yes. Monthly ianalumab produced a statistically significant greater average improvement in ESSDAI disease-activity scores than placebo in both NEPTUNUS trials, although the differences were small.
Did the trials show that ianalumab improves Sjögren’s symptoms?
The published results did not establish a clear benefit over placebo for several key secondary outcomes, including measures related to dryness and patient-reported symptoms. Some results favored the drug numerically, but they were not consistently significant.
Has Novartis filed for approval?
The source report says Novartis had not clarified whether it submitted the marketing applications it had planned for the third quarter of 2026. The filing status remains unconfirmed in the available information.
What is the THALASSA trial?
THALASSA is a new placebo-controlled phase III study of ianalumab in Sjögren’s patients with high symptom burden. It is planned to enroll 570 people, with primary completion estimated for August 2029.
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