Novartis Says Phase 3 Sjögren’s Disease Trials Met Primary Endpoints

Rare Daily Staff

Novartis reported that two phase 3 trials evaluating its experimental therapy, ianalumab, in adults with active Sjögren’s disease met their primary endpoints, demonstrating statistically significant improvements in disease activity.

Sjögren’s is a rare, systemic, chronic autoimmune disorder that causes inflammation and tissue damage, impacting the entire body. It primarily affects the exocrine glands, resulting in excessive dryness; over 90% of patients experience dry eyes and dry mouth. The disease is heterogeneous; patients experience dryness, fatigue, and widespread pain. Some 30–40 percent of patients also show organ involvement, which can include effects on the skin, musculoskeletal system, kidneys, lungs, and other organs. The risk of lymphoma is increased in patients with Sjögren’s.

Ianalumab is a fully human monoclonal antibody being explored for its potential to treat various B cell-driven autoimmune diseases, including Sjögren’s disease, immune thrombocytopenia, systemic lupus erythematosus, lupus nephritis, warm autoimmune hemolytic anemia, and diffuse cutaneous systemic sclerosis. Ianalumab works by combining B cell depletion with interruption of BAFF-R mediated signals that drive B cell function and survival.

The NEPTUNUS pivotal trials achieved their primary endpoint of improving disease activity, as measured by a reduction in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), a multi-dimensional disease activity measurement, compared to placebo. Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren’s disease.

In clinical trials, ianalumab exhibited promising efficacy and a favorable safety profile in Sjögren’s disease, systemic lupus erythematosus, and immune thrombocytopenia. Ianalumab originates from an early collaboration with MorphoSys AG, a company that Novartis acquired in 2024.

Novartis plans to present the NEPTUNUS-1 and NEPTUNUS-2 data at an upcoming medical meeting and submit ianalumab—which was granted Fast Track Designation by the U.S. Food and Drug Administration—to health authorities globally.

“Both phase 3 trials demonstrate that ianalumab improves disease activity in patients with Sjögren’s disease,” said Shreeram Aradhye, president of development and chief medical officer at Novartis.

Photo: Shreeram Aradhye, president of development and chief medical officer at Novartis.