In short
There is currently 1 ongoing clinical trial for autoimmune hepatitis, a chronic condition where the immune system mistakenly attacks the liver. This trial is investigating a new treatment option for patients who have not responded well to or cannot tolerate standard therapies. The trial is being conducted in multiple European countries.
Clinical trial locations
- Czechia
- Germany
Study on the Effects of VAY736 for Patients with Autoimmune Hepatitis Who Do Not Respond Well to Standard Treatment
This trial is investigating VAY736, also known as ianalumab, a monoclonal antibody designed to target specific parts of the immune system. The medication is being compared with a placebo to determine whether it can help patients whose condition has not improved with standard treatments or who cannot tolerate existing therapies.
Main focus and goal: The primary purpose of this study is to evaluate whether VAY736 can help normalize levels of alanine aminotransferase (ALT), a liver enzyme that becomes elevated when the liver is inflamed or damaged. The trial is conducted in two parts: the first part determines the best dose of VAY736 by monitoring its effects over 24 weeks, while the second part confirms the benefits and safety of the selected dose. The ultimate goal is to find a new treatment option for patients with limited success with current therapies.
Who can participate - inclusion criteria:
- Adults aged 18 to 75 years
- Confirmed diagnosis of Type 1 autoimmune hepatitis according to international criteria, with the presence of specific antibodies
- Recent liver biopsy showing signs consistent with the condition (Ishak modified HAI score of 5 or more), performed either during screening or within 6 months prior
- Either incomplete response to standard therapy (ALT levels 1.5 times the upper limit of normal after at least 6 months of treatment) or intolerance to standard therapy due to side effects
- Stable doses of corticosteroids or azathioprine maintained during the screening period and throughout treatment
- Patients currently taking mycophenolate mofetil or mycophenolic acid may participate, but these medications will be stopped or replaced with azathioprine during a pre-screening period
Who cannot participate - exclusion criteria:
- Patients with other serious liver diseases besides autoimmune hepatitis
- Previous liver transplant recipients
- Active infections requiring treatment with antibiotics, antivirals, or antifungals
- History of cancer within the last 5 years, except for certain skin cancers
- Pregnant or breastfeeding women
- History of drug or alcohol abuse within the past year
- Known allergy to the study medication or its ingredients
- Current participation in another clinical trial
- Certain heart conditions, including uncontrolled high blood pressure or heart failure
- Severe kidney problems
Investigational drug: VAY736 is administered as an injection under the skin. It works as a monoclonal antibody, meaning it is a specially designed protein that interacts with specific molecules in the body to help modulate the immune system. By targeting proteins involved in the immune response, VAY736 aims to reduce inflammation and liver damage. The trial will monitor changes in liver health and any side effects experienced by participants over the 24-week treatment period.
Summary
Currently, there is one clinical trial available for patients with autoimmune hepatitis who have not had success with standard treatments. This trial is taking place in Czechia and Germany, offering access to an experimental treatment called VAY736. The study focuses specifically on patients with incomplete response to or intolerance of conventional therapies, representing an important research effort for this particular patient group. The trial uses a rigorous approach with a placebo comparison to carefully evaluate both the safety and effectiveness of this new treatment approach.
