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Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called ianalumab for patients with Sjögren’s syndrome. Sjögren’s syndrome is an autoimmune disease where the body's immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and dry eyes. The study involves the use of ianalumab, which is administered as a solution for injection. Participants in the study may also receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of the study is to assess how well ianalumab works over a long period and to monitor any side effects that may occur. Participants will be randomly assigned to receive either ianalumab or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will continue for several years, allowing researchers to gather comprehensive data on the treatment's safety and effectiveness.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. Blood samples will be taken to measure the levels of ianalumab in the body and to check the number of B-cells, which are a type of immune cell. The study aims to provide valuable information on the potential benefits of ianalumab for people living with Sjögren’s syndrome, contributing to better treatment options in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing an informed consent form. This confirms understanding and agreement to participate in the study.

    Eligibility requires previous participation in one of the NEPTUNUS core studies and completion of treatment up to Week 48 without discontinuation.

  2. Step 2

    Treatment phase

    The main objective is to assess the long-term safety and tolerability of ianalumab in individuals with Sjögren’s syndrome.

    Participants receive ianalumab administered subcutaneously. The specific dosage and frequency are determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Regular monitoring includes checking for any treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).

    Assessments involve measuring changes in the ESSDAI and ESSPRI scores, which evaluate disease activity and symptoms.

    Blood samples are collected to measure ianalumab serum concentrations and B-cell counts at specified intervals, such as Week 52 and Week 64.

  4. Step 4

    Follow-up

    The study continues with follow-up assessments to monitor long-term effects and safety up to Week 204.

    Participants' progress and response to treatment are evaluated throughout the study duration, which is estimated to end by January 6, 2031.

Who can join the trial?

5 criteria

  • You must have signed a document called an informed consent before joining the study. This document explains the study and confirms that you agree to participate.
  • You must have taken part in one of the two previous studies named NEPTUNUS, specifically studies CVAY736A2301 or CVAY736A2302, and completed all treatments up to Week 48 without stopping the treatment early.
  • The study doctor must believe that you will continue to benefit from the treatment with the medication called ianalumab.
  • Both men and women can participate in the study.
  • The study is open to adults, which means you must be at least 18 years old.

Who cannot join the trial?

10 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to medications.
  • Using certain medications that might affect the study results.
  • Having participated in another clinical trial recently.
  • Having a history of drug or alcohol abuse.
  • Having an infection that requires treatment with antibiotics.
  • Having a history of cancer, except for some types of skin cancer.
  • Having a weakened immune system, which means the body's defense against infections is not strong.
  • Having a history of certain blood disorders.
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Investigated drugs

Ianalumab is a medication being studied for its long-term safety and effectiveness in treating patients with Sjögren’s syndrome. Sjögren’s syndrome is an autoimmune disease that primarily affects the glands that produce tears and saliva, leading to dry mouth and eyes. Ianalumab is designed to help manage the symptoms of this condition by targeting specific parts of the immune system. The goal of the study is to determine how well patients tolerate the medication over an extended period and to evaluate its overall safety.

What is already known about the treatment

Ianalumab – Ianalumab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating Sjögren’s syndrome, an autoimmune condition. The medication works by targeting specific proteins in the immune system to reduce inflammation and other symptoms associated with the disease. Ianalumab is classified as a monoclonal antibody, which is a type of medication designed to interact with specific molecules in the body to modify immune responses.

Investigated diseases

Sjögren’s syndrome – Sjögren’s syndrome is an autoimmune disorder primarily affecting the glands that produce tears and saliva, leading to dry eyes and mouth. It can also affect other parts of the body, including joints, skin, and organs. The disease progresses slowly, with symptoms often developing over several years. Patients may experience fatigue, joint pain, and swelling. In some cases, it can lead to complications such as dental cavities, oral yeast infections, or vision problems. The severity and progression of symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502966-26-01Protocol codeCVAY736A2301E1Estimated enrolment753 patientsSponsorNovartis Pharma AG

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