Not recruiting

Study on Ianalumab for Patients with Systemic Lupus Erythematosus

Fast replyRegistered drug

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 a disease called Systemic Lupus Erythematosus (SLE), which is an autoimmune condition where the body's immune system mistakenly attacks its own tissues. The study is testing a treatment called ianalumab, also known by its code name VAY736. This treatment is given as a solution for injection using a pre-filled syringe. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of ianalumab when used alongside standard treatments for SLE.

Participants in the study will receive either ianalumab or a placebo, which is a substance with no active medication. The study will last for about 60 weeks, during which participants will receive monthly injections. The goal is to see if ianalumab can help improve the condition of patients with SLE by achieving a specific response known as the Systemic Lupus Erythematosus Responder Index (SRI-4) by the end of the study period.

Throughout the study, researchers will monitor participants for any changes in their condition, including the occurrence of flare-ups, which are periods when symptoms worsen. They will also track the use of corticosteroids, a type of medication often used to manage SLE symptoms, to see if ianalumab can help reduce the need for these drugs. The study will also assess the overall health and well-being of participants, including any side effects they may experience. The information gathered will help determine if ianalumab is a beneficial addition to the current standard of care for people with SLE.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of systemic lupus erythematosus (SLE), and current treatment regimen.
Participants must have elevated serum titers of antinuclear antibodies and meet certain disease activity levels.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health status and disease activity using the SLEDAI-2K score and other measures.
Participants' weight and other vital signs are recorded.
Step 3
Treatment administration
Participants receive either ianalumab or a placebo. Ianalumab is administered as a subcutaneous injection at a dose of 300 mg once a month.
The treatment is given in a pre-filled syringe as a solution for injection.
Step 4
Ongoing monitoring
Participants are monitored regularly for any changes in disease activity and side effects.
Regular assessments include clinical laboratory measurements, vital signs, and the presence of anti-ianalumab antibodies.
Step 5
Evaluation of outcomes
The primary goal is to assess the proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI-4) at Week 60.
Secondary outcomes include maintaining reduced corticosteroid doses and achieving low disease activity states.
Step 6
Completion of study
The study is expected to conclude by January 23, 2029.
Final assessments will determine the long-term efficacy and safety of ianalumab in treating SLE.

Who can join the trial?

7 criteria

Participants must be male or female and at least 12 years old at the time of screening. In some countries, participants must be 18 years or older.
Participants must have a diagnosis of Systemic Lupus Erythematosus (SLE) that meets specific classification criteria for at least 6 months before screening.
Participants must have elevated levels of certain antibodies in their blood, known as Antinuclear Antibodies, with a specific pattern, as determined by a central laboratory.
Participants must currently be receiving treatment with corticosteroids, anti-malarial medication, or another type of medication called a Disease-modifying antirheumatic drug (DMARD).
Participants must have a certain score on a test called the SLEDAI-2K, which measures disease activity, with a score of at least 6 points. Some points are excluded, such as those for "fever," "lupus headache," "hair loss," and "organic brain syndrome."
Participants must have a certain level of disease activity in at least one organ system or in two organ systems, as measured by a specific assessment group.
Participants must weigh at least 35 kg at the time of screening.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment.
Patients who have received certain medications that might affect the study results.
Patients with a history of drug or alcohol abuse.
Patients who have participated in another clinical trial recently.
Patients with a known allergy to the study medication.
Patients who have had a recent surgery or are planning to have surgery during the study.
Patients with a history of cancer, except for certain types of skin cancer.
Patients with a history of heart problems, such as heart attack or heart failure.

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

Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Verified
Milan, Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Spitalul Clinic Judetean De Urgenta Cluj
Responsive
Cluj Napoca, Romania

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 effectiveness, safety, and tolerability in patients with Systemic Lupus Erythematosus (SLE). It is administered as a subcutaneous injection and is being tested to see if it can improve the condition of patients when used alongside standard treatments. The goal is to determine if it can help patients achieve a better response to their lupus symptoms over a period of 60 weeks.

What is already known about the treatment

Ianalumab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in a Phase 3 clinical trial for its effectiveness in treating Systemic Lupus Erythematosus, a chronic autoimmune disease. Ianalumab works by targeting specific immune cells to reduce inflammation and disease activity. It is classified as a monoclonal antibody, which is a type of protein designed to bind to specific targets in the body.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease is characterized by periods of illness, called flares, and periods of wellness, or remission. Symptoms can vary widely among individuals and may include fatigue, joint pain, skin rashes, and fever. Over time, SLE can lead to inflammation and damage to the affected organs. The progression of the disease is unpredictable, with symptoms ranging from mild to severe.