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Phase III trial evaluating ianalumab with background drug combination in patients with Sjögren's disease

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What is this trial about?

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

Sjögren's disease is an autoimmune condition that mainly causes dry eyes and dry mouth because the body’s immune system attacks the glands that produce tears and saliva. The trial is testing a new medicine called ianalumab (code name VAY736) that is given as a subcutaneous injection, and it is being compared with a placebo.

The purpose of the study is to find out whether ianalumab can improve symptoms more than placebo, measured by the change in the oral dryness score of the Sjögren's Syndrome Symptom Diary after about one year. Participants will be randomly assigned to receive either the study drug or placebo, will attend regular clinic visits for roughly 52 weeks, complete symptom questionnaires, and have routine safety checks such as blood tests and vital‑sign measurements. All side effects and any health problems that occur during the study will be recorded.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessment
After joining the study, you will sign an informed consent form and provide basic health information.
A baseline evaluation will be performed, which includes completing the sjogren's syndrome symptom diary, providing blood samples for routine laboratory tests, and recording vital signs.
Step 2
Start background oral medications
You will begin taking the following oral medications every day:
tenofovir disoproxil 50 mg taken by mouth once daily;
tenofovir alafenamide 25 mg taken by mouth once daily;
entecavir 0.5 mg taken by mouth once daily.
These medicines are continued for the entire 52‑week study period unless your doctor advises otherwise.
Step 3
First subcutaneous injection of study drug or placebo
A healthcare professional will give you a single subcutaneous (under the skin) injection of either the study drug ianalumab (vay736) or a matching placebo.
The injection is administered at the start of the study (week 0).
Step 4
Regular subcutaneous injections
Additional injections of the study drug or placebo are given at regular intervals as defined by the protocol, typically every four weeks.
The schedule continues for a total treatment duration of 52 weeks.
Step 5
Daily symptom diary entries
Each day you will record your symptoms in the sjogren's syndrome symptom diary, focusing on oral dryness, eye dryness and overall discomfort.
The diary information is used to evaluate changes in your condition over time.
Step 6
Periodic clinic visits for safety monitoring
You will attend scheduled clinic visits throughout the study (for example, at weeks 4, 12, 24, and 52).
During each visit, blood samples will be taken for routine hematology and clinical chemistry tests, vital signs will be measured, and any adverse events will be reviewed.
Step 7
Final assessment at week 52
At the end of week 52, a final evaluation will be performed.
The primary outcome is the change from baseline in the oral dryness score of the sjogren's syndrome symptom diary.
Secondary outcomes include changes in overall symptom scores, fatigue, quality of life, and safety assessments.

Who can join the trial?

8 criteria

Be at least 18 years old (or older if your country’s legal adult age is higher).
Have a diagnosis of Sjögren’s disease that meets the ACR/EULAR 2016 criteria (standard guidelines doctors use to confirm the disease).
Test positive for anti‑Ro/SSA antibodies (a blood test that shows your immune system is making specific proteins linked to Sjögren’s).
Have an oral dryness score of 5 or more on the Sjögren’s Syndrome Symptom Diary (SSSD), and an overall SSSD score of 5 or more, recorded over 14 straight days during the screening period.
Have a score greater than 0 in the ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) for the biologic or blood‑cell (hematologic) part of the test, showing some disease activity. Lab results must be due to Sjögren’s, not another illness. Testing for cryoglobulins can be included but is not required.
Produce more than 0.3 mL of saliva per minute when stimulated (measured as stimulated whole salivary flow rate) during screening.
If you are already taking hydroxychloroquine (up to 400 mg each day), you must have been on a stable dose for at least 4 weeks before screening and keep the same dose for the 52‑week study.
If you are using prednisone or prednisolone (a type of steroid), you must be on 5 mg per day or less (or an equivalent amount) for at least 4 weeks before screening. You may continue this dose for up to 16 weeks after randomization, and the dose must be gradually reduced (tapered) to 2.5 mg or less within 16 weeks, aiming to stop the steroid if possible.

Who cannot join the trial?

7 criteria

You have another active autoimmune rheumatic disease that is the main health problem, such as moderate‑to‑severe systemic lupus erythematosus (SLE) with kidney involvement, active rheumatoid arthritis, systemic sclerosis, or other connective‑tissue diseases (like lupus kidney disease, large‑vessel vasculitis, or mixed connective‑tissue disease) that need strong immune‑suppressing medicines outside this study.
You have a current or past diagnosis of fibromyalgia or other overlapping inflammatory diseases.
You received a B‑cell‑depleting therapy (for example, rituximab or other drugs that target CD20, CD22, or CD52) within the last 36 weeks, or your B‑cell count is still lower than normal at the screening visit.
You have taken ialanumab before.
You have used certain biologic medicines—such as iscalimab (anti‑CD40), belimumab (anti‑BAFF), abatacept, anti‑TNFα agents, immune‑globulin infusions, plasmapheresis, or any other investigational biologic for Sjögren’s disease—within five half‑lives (the time it takes for half the drug to leave the body) before screening.
You have used specific immunosuppressant drugs—including cyclophosphamide, mycophenolate mofetil, methotrexate, azathioprine, cyclosporine, JAK inhibitors, or similar medicines—within four weeks (or longer if the drug’s half‑life is longer) before screening.
You have a known hypersensitivity (allergic reaction) to any of the study drugs, to similar monoclonal antibodies of the IgG1 class, or to ingredients such as sucrose, L‑histidine hydrochloride, or polysorbate 20.

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Verified sites

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

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centre Hospitalier Departemental Vendee
Verified
La Roche sur Yon, France
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

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Investigated drugs

Tenofovir disoproxil (combined with emtricitabine)
is an oral tablet that contains two antiviral medicines. These drugs work by stopping a virus from copying its genetic material, which helps control infections such as hepatitis B. In this study participants continue to take this medication as part of their regular treatment while the new therapy is tested.
Tenofovir alafenamide
is another oral antiviral pill. Like the other tenofovir product, it blocks the virus’s ability to multiply, but it is formulated to deliver the active drug more efficiently to the liver. Participants may be using this medication as part of their standard care during the trial.
Entecavir
is a daily oral tablet used to treat chronic hepatitis B infection. It works by interfering with the virus’s replication process, helping to keep the infection under control. In the trial, participants who are already on this medicine keep using it while the investigational drug is studied.
Glucocorticoids
are a class of steroid drugs that reduce inflammation and suppress the immune system. They are often prescribed for a variety of conditions that involve swelling or an overactive immune response. Some participants may be taking a glucocorticoid as part of their usual therapy while the study drug is evaluated.
Ianalumab
(code name VAY736) is an experimental medicine that is given as a subcutaneous injection (under the skin). It is a type of antibody designed to target specific parts of the immune system that are thought to contribute to the dryness and other symptoms of Sjögren’s disease. The trial is testing whether ianalumab can improve oral dryness and overall symptom burden compared with a placebo.

What is already known about the treatment

Tenofovir disoproxil
This medication is taken by mouth as a tablet. It is an approved drug that has been used for many years in the treatment of viral infections. It is mainly prescribed for chronic hepatitis B and for preventing HIV infection in people at risk. It works by blocking an enzyme that the virus needs to copy its genetic material, and it belongs to the class of nucleoside reverse‑transcriptase inhibitors.
Tenofovir alafenamide
This drug is also taken orally in tablet form. It is a newer, approved version of tenofovir that is commonly used for hepatitis B and HIV. It is used to treat chronic hepatitis B infection and to prevent HIV in high‑risk individuals. It delivers the active drug into cells more efficiently, inhibiting the viral enzyme needed for replication, and it is classified as a nucleotide reverse‑transcriptase inhibitor.
Entecavir
Entecavir is an oral tablet taken by mouth. It is an established, approved medication for chronic hepatitis B infection. Its main use is to suppress hepatitis B virus replication in people with long‑term infection. It blocks a viral enzyme called polymerase, stopping the virus from copying its DNA, and it is classified as a nucleoside analogue antiviral.
Ianalumab
Ianalumab is given as a subcutaneous injection using a pre‑filled pen. It is an experimental drug currently being studied in clinical trials for autoimmune diseases. The trial is testing it for Sjögren’s disease, an immune disorder that causes dry mouth and eyes. It works by binding to the CD40 protein on immune cells, reducing their activation, and it belongs to the class of monoclonal antibodies that target immune pathways.

Investigated diseases

Sjögren's syndrome - Sjögren's syndrome is an autoimmune disorder that mainly affects the moisture‑producing glands. It causes the eyes and mouth to become dry because the glands produce less fluid. Over time, dryness can spread to the nose, throat, skin, and other organs. The condition may also lead to swelling of the glands and occasional joint pain. Symptoms often develop slowly and can become more noticeable as the disease progresses.