VAY736 dose testing; VAY736 efficacy and safety testing.

This is a randomized, placebo-controlled, double-blind dose range study in autoimmune hepatitis. The study population consists of female and male adult autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care. The diagnosis of autoimmune hepatitis has to fulfill the IAIHG criteria and must be confirmed by liver histology.

Patients will be randomly assigned to different doses of VAY736 or placebo. The primary analysis is planned at 24 weeks. A subsequent study part will then test the efficacy and safety of VAY736 in a parallel group design. For this part of the trial a new group of autoimmune hepatitis patients will be enrolled.

Key Inclusion Criteria:

1. AIH diagnosed per International Autoimmune Hepatitis Group
2. Liver biopsy with Ishak modified HAI indicating active AIH
3. Incomplete response to OR intolerance of standard therapy (per AASLD)

Key Exclusion Criteria

1. Prior use of any B-cell depleting therapy (e.g., rituximab or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb) within 1 year prior to Screening or as long as B-cell count <50 cells/µL
2. Required regular use of medications with known hepatotoxicity
3. Decompensated cirrhosis
4. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
5. Drug related AIH at screening or a history of drug related AIH.
6. History of drug abuse or unhealthy alcohol use
7. History of malignancy of any organ system
8. Pregnant or nursing (lactating) women

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Double blind, placebo-controlled