ADCC Mediated B-Cell dEpletion and BAFF-R Blockade
A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis
ClinicalTrials.gov Identifier: NCT03217422
Novartis Reference Number: CVAY736B2201
Last Update: Sep 21, 2022
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.
Study Description
VAY736 dose testing; VAY736 efficacy and safety testing.
Interventions
Eligibility Criteria
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
Decompensated cirrhosis
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
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]