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A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Join a study on Ianalumab's safety for Sjogren's Syndrome.

Recruiting
18-75 years
All
Phase 3

Sjogren's syndrome is a disease where the body's immune system attacks its own cells, causing dryness in the mouth and eyes. This study is for people who have already been part of a previous study called NEPTUNUS. It aims to see how safe and effective a drug called ianalumab is over a long time. Ianalumab is a medicine given by a shot under the skin, using a pre-filled syringe. The study will last for up to 5 years, with 3 years of treatment and up to 2 years of follow-up. There are about 600 participants expected, and visits will be mostly monthly.

  • The study lasts up to 5 years with regular visits.
  • Participants receive a medicine called ianalumab, either every month or every 3 months.
  • There are no new participants; only those from prior studies can join.

Before joining, participants must have completed a previous study and should not plan to take certain other medicines or vaccines. Pregnant or nursing women cannot join. Women who could become pregnant must use effective birth control. Safety is closely monitored, and study members can learn to self-inject at home after training. This study helps researchers understand if ianalumab is safe and works well for people with Sjogren's syndrome over a long time.

Study details
    Sjogrens Syndrome

NCT05985915

Novartis Pharmaceuticals

9 March 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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