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 study about?

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.

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.

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.

3 randomization and treatment

Participants are randomly assigned to receive either VAY736 or a placebo.

The medication is administered as a subcutaneous injection.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country	Status
Klin Med s.r.o.	Prague	Czechia
Usogkejjlm Mqqsive Cdtbhq Hvucprcznktazmbsf	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	18.02.2018
Germany	Not recruiting	18.02.2018

Trial locations

Investigated drugs:

Ianalumab

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.

Investigated diseases:

Autoimmune hepatitis

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.

Trial ID:

2023-508859-39-00

Protocol code:

CVAY736B2201

NCT ID:

NCT03217422

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?