Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 effects of a medication called ianalumab in adults with autoimmune diseases, specifically Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Sjögren’s Disease. Autoimmune diseases occur when the body's immune system mistakenly attacks its own tissues. The study aims to compare how the body processes ianalumab when given in different forms, such as a pre-filled syringe or an auto-injector. Ianalumab is a type of protein-based medication designed to help manage these conditions by targeting specific parts of the immune system.

Participants in the study will receive ianalumab through subcutaneous injections, which means the medication is administered under the skin. The study will take place over a period of time, allowing researchers to observe how the medication is absorbed and processed by the body. The goal is to ensure that the different forms of administering ianalumab are equally effective and safe for patients. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of ianalumab.

In addition to ianalumab, the study will also involve other medications such as emtricitabine, tenofovir disoproxil, tenofovir alafenamide, and entecavir, which are typically used to manage viral infections. These medications will be administered orally, meaning they are taken by mouth. The study will monitor various health indicators, including any side effects, to ensure the safety and effectiveness of the treatments. The overall purpose is to gather information that could lead to better treatment options for people with these autoimmune diseases.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will have already provided signed informed consent. This is a necessary step before any assessments or treatments begin.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes verifying age, weight, body mass index (BMI), and diagnosis of rheumatoid arthritis, systemic lupus erythematosus, or Sjögren’s disease.

  3. Step 3

    Treatment phase 1

    Participants will receive ianalumab, a medication administered subcutaneously (under the skin). The dosage is 300 mg, and it will be given using either a 2 mL auto-injector or two 1 mL pre-filled syringes.

    This phase aims to compare how the body absorbs and processes the medication using different delivery methods.

  4. Step 4

    Monitoring and evaluation

    Participants will be monitored for serum concentrations of ianalumab at specific intervals after the third dose (between weeks 8 and 12) and the sixth dose (between weeks 20 and 24).

    Additional evaluations will include checking for adverse events, laboratory tests, vital signs, and ECG parameters.

  5. Step 5

    Treatment phase 2 (optional)

    In an optional second phase, participants may receive ianalumab using a different combination of delivery methods: a 2 mL pre-filled syringe or two 1 mL pre-filled syringes.

    This phase also focuses on comparing how the body absorbs and processes the medication.

  6. Step 6

    Final assessments

    At the end of the study, participants will undergo final assessments to evaluate the presence of anti-ianalumab antibodies and any other long-term effects of the treatment.

Who can join the trial?

7 criteria

  • You must sign a form to show you understand and agree to join the study before any tests are done.
  • You need to be between 18 and 70 years old.
  • Your body weight should be at least 35 kg and not more than 150 kg. Your Body Mass Index (BMI) should be between 18 and 35. BMI is a number calculated from your weight and height.
  • You must have been diagnosed with one of the following conditions: Rheumatoid Arthritis (RA), Sjögren’s Disease (SjD), or Systemic Lupus Erythematosus (SLE).
  • Your condition (RA, SjD, or SLE) should be active and might improve with a treatment that reduces certain immune cells called B-cells.
  • If you are taking any regular medications allowed by the study, you should have been on a stable dose for at least 4 weeks before starting the study treatment.
  • You should be able to communicate well with the study doctor and understand and agree to follow the study's requirements.

Who cannot join the trial?

3 criteria

  • Patients with **Rheumatoid Arthritis** cannot participate. This is a condition where the body's immune system attacks its own joints, causing pain and swelling.
  • Patients with **Systemic Lupus Erythematosus** are excluded. This is a disease where the immune system attacks different parts of the body, like the skin, joints, and organs.
  • Patients with **Sjögren’s Disease** cannot join. This is a condition where the immune system attacks glands that produce moisture, like tears and saliva.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Ianalumab is a medication being studied for its effects on autoimmune diseases. In this clinical trial, researchers are examining how the body absorbs and processes ianalumab when it is given in different forms. The study compares the use of an auto-injector and pre-filled syringes to see if they deliver the medication in a similar way. This helps ensure that patients receive the same benefits from the medication, regardless of how it is administered.

What is already known about the treatment

Ianalumab – Ianalumab is administered subcutaneously, typically using an auto-injector or pre-filled syringe. It is currently being studied in clinical trials for its effectiveness in treating autoimmune diseases such as Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Sjögren’s Disease. The medication works by targeting specific proteins in the immune system to reduce inflammation and immune response. Ianalumab is classified as a monoclonal antibody, which is a type of biologic drug designed to interact with specific molecules in the body.

Investigated diseases

  • Rheumatoid Arthritis

    A chronic inflammatory disorder that primarily affects the joints, causing pain, swelling, and stiffness. Over time, it can lead to joint damage and deformities. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees and hips. It may also affect other body systems, including the skin, eyes, and lungs. The exact cause is unknown, but it involves the immune system attacking the body's own tissues. Symptoms can vary in severity and may come and go.

  • Systemic Lupus Erythematosus

    An autoimmune disease where the immune system attacks healthy tissues, affecting multiple organs and systems. It can cause a wide range of symptoms, including fatigue, joint pain, skin rashes, and fever. The disease is characterized by periods of illness, called flares, and periods of remission. It can affect the skin, kidneys, brain, and other organs. The exact cause is unknown, but it is believed to involve genetic and environmental factors. Symptoms can vary greatly between individuals.

  • Sjögren’s Disease

    An autoimmune disorder characterized by dry eyes and dry mouth due to the body's immune system attacking its own moisture-producing glands. It can also affect other parts of the body, including the joints, thyroid, kidneys, liver, and lungs. The disease often accompanies other autoimmune disorders, such as rheumatoid arthritis or lupus. Symptoms can include difficulty swallowing, persistent dry cough, and fatigue. The cause is not fully understood, but it involves a combination of genetic and environmental factors. Symptoms can range from mild to severe.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508996-35-00Protocol codeCVAY736A2202Estimated enrolment167 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.