Not recruitingRare disease

Study on the Effects of VAY736 for Patients with Autoimmune Hepatitis Who Do Not Respond Well to Standard Treatment

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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 autoimmune hepatitis, a condition where the body's immune system mistakenly attacks the liver. The study is investigating a treatment called VAY736, also known as ianalumab, which is a type of protein designed to target specific parts of the immune system. The trial will compare the effects of VAY736 with a placebo to see if it can help patients who have not responded well to or cannot tolerate standard treatments.

The purpose of the study is to evaluate the safety and effectiveness of VAY736 in improving liver function in patients with autoimmune hepatitis. The study is divided into two parts. In the first part, researchers will determine the best dose of VAY736 by observing its effects on liver enzyme levels over 24 weeks. In the second part, the chosen dose will be tested further to confirm its benefits and safety for patients.

Participants in the study will receive either VAY736 or a placebo through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor changes in liver health and any side effects experienced by participants. The goal is to find a new treatment option for those with autoimmune hepatitis who have limited success with existing therapies.

The research process

The trial runs in 5 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, informed consent is required. This means agreeing to participate after understanding the study details.
Eligibility is confirmed based on specific criteria, including age and diagnosis of autoimmune hepatitis.
Step 2
Screening period
During the screening period, stable doses of medications such as corticosteroids or azathioprine are maintained.
If taking mycophenolate mofetil or mycophenolic acid, these are adjusted or replaced as needed.
Step 3
Randomization and treatment
Participants are randomly assigned to receive either VAY736 or a placebo.
The medication is administered as a subcutaneous injection.
Step 4
Treatment duration
The treatment lasts for 24 weeks.
The goal is to assess the normalization of alanine aminotransferase (ALT) levels, a liver enzyme, by the end of this period.
Step 5
Evaluation
The primary outcome is the proportion of patients achieving ALT normalization at Week 24.
Secondary evaluations may include additional biochemical and histological assessments.

Who can join the trial?

8 criteria

You must provide written informed consent before any study assessments are performed.
You should be a male or female aged between 18 to 75 years.
You must have Type 1 **Autoimmune Hepatitis (AIH)**, diagnosed according to specific international criteria, which includes the presence of certain antibodies in your blood.
You need to have a liver biopsy result that matches autoimmune hepatitis, either done during the screening or within 6 months before screening, and it should show a specific score (Ishak modified HAI score of 5 or more).
You should have either an incomplete response to or intolerance of standard therapy. This means:
- **Incomplete responder**: Your **alanine aminotransferase (ALT)** level, a liver enzyme, is 1.5 times the upper limit of normal during screening, and you have been on standard therapy for at least 6 months.
- **Intolerant**: Your ALT level is 1.5 times the upper limit of normal during screening, and you had to stop standard therapy due to side effects.
- You must be on stable doses of certain medications like corticosteroids or azathioprine during the 4-week screening period and throughout the treatment periods. The doses should not exceed specific limits.
- If you have previously taken medications like mycophenolate mofetil (MMF) or mycophenolic acid (MPA), you can still participate. However, if you are currently taking these medications, they will be stopped or changed to azathioprine during a pre-screening period.

Who cannot join the trial?

10 criteria

Patients who have other serious liver diseases besides autoimmune hepatitis cannot participate. Autoimmune hepatitis is a condition where the body's immune system attacks the liver.
Patients who have had a liver transplant are not eligible.
Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are excluded.
Patients with a history of cancer within the last 5 years, except for certain skin cancers, cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who have a history of drug or alcohol abuse within the past year are excluded.
Patients who have a known allergy to the study medication or its ingredients cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients with certain heart conditions, such as uncontrolled high blood pressure or heart failure, are excluded.
Patients with severe kidney problems cannot join the study.

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
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Mainz, Germany
University Medical Center Hamburg-Eppendorf
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Hamburg, Germany

Trial locations

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Investigated drugs

VAY736 is a medication being studied for its potential to help patients with autoimmune hepatitis who do not respond well to or cannot tolerate standard treatments. The trial aims to see if VAY736 can improve liver function by normalizing a specific liver enzyme level, known as alanine aminotransferase (ALT), and to confirm its overall effectiveness and safety in achieving remission of the disease.

Ianalumab

What is already known about the treatment

VAY736 – VAY736 is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its potential use in treating autoimmune hepatitis, particularly in patients who do not respond well to or cannot tolerate standard treatments. The medication works by targeting specific proteins involved in the immune response, helping to reduce inflammation and liver damage. VAY736 is classified as a monoclonal antibody, a type of drug designed to interact with specific molecules in the body to modulate the immune system.

Investigated diseases

Autoimmune Hepatitis – Autoimmune hepatitis is a chronic disease where the body's immune system mistakenly attacks liver cells, causing inflammation. Over time, this inflammation can lead to liver damage, including scarring and cirrhosis. The disease often presents with symptoms such as fatigue, abdominal discomfort, and jaundice, although some individuals may remain asymptomatic for years. The progression of autoimmune hepatitis can vary, with some experiencing a slow course while others may have rapid liver damage. It is characterized by elevated liver enzymes, particularly alanine aminotransferase (ALT), and the presence of specific autoantibodies in the blood. The exact cause of the immune system's attack on liver cells is not fully understood, but it is believed to involve a combination of genetic and environmental factors.