All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
VAY736 dose testing; VAY736 efficacy and safety testing.
Feb 15, 2018
Dec 29, 2023
18 Years - 75 Years (Adult, Older Adult)
Placebo control with conversion to active VAY736
Key Inclusion Criteria:
AIH diagnosed per International Autoimmune Hepatitis Group
Liver biopsy with Ishak modified HAI indicating active AIH
Incomplete response to OR intolerance of standard therapy (per AASLD)
Key Exclusion Criteria
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
Required regular use of medications with known hepatotoxicity
Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
Drug related AIH at screening or a history of drug related AIH.
History of drug abuse or unhealthy alcohol use
History of malignancy of any organ system
Pregnant or nursing (lactating) women