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

See if you pre-qualify

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.

Condition 
Autoimmune Hepatitis
Phase 
Phase 2
Phase 3
Overall status 
Recruiting
Start date 
Feb 15, 2018
Completion date 
Dec 29, 2023
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Biological
VAY736
VAY736
Other
Placebo
Placebo control with conversion to active VAY736

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

United States
Novartis Investigative Site
Recruiting
Coronado, 92118
California
United States
Novartis Investigative Site
Recruiting
Rialto, 92377
California
United States
Novartis Investigative Site
Recruiting
Sacramento, 95817
California
United States
Novartis Investigative Site
Recruiting
Denver, 80262
Colorado
United States
Novartis Investigative Site
Recruiting
New Haven, 06510
Connecticut
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Recruiting
New Orleans, 70112
Louisiana
United States
Novartis Investigative Site
Recruiting
Detroit, 48202
Michigan
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1056ABJ
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Caba, C1181ACH
Buenos Aires
Argentina
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Calgary, T2N 4N1
Alberta
Canada
Novartis Investigative Site
Recruiting
Edmonton, T6G 2B7
Alberta
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 2C4
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H2X 1R9
Quebec
Canada
Czech Republic
Novartis Investigative Site
Recruiting
Prague, 12000
-
Czech Republic
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20246
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Tübingen, 72076
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Japan
Novartis Investigative Site
Recruiting
Toon-city, 791-0295
Ehime
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 814 0180
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Sapporo-city, 006-8555
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Takamatsu city, 760 8557
Kagawa
Japan
Novartis Investigative Site
Recruiting
Itabashi ku, 173 8606
Tokyo
Japan
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
San Sebastian, 20080
Pais Vasco
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Lugano, 6900
-
Switzerland
United Kingdom
Novartis Investigative Site
Recruiting
Birmingham, B15 2TH
-
United Kingdom
Novartis Investigative Site
Recruiting
London, NW3 2PF
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE5 9RS
-
United Kingdom
Novartis Investigative Site
Recruiting
Newcastle upon Tyne, NE1 4LP
-
United Kingdom
Novartis Investigative Site
Recruiting
Nottingham, NG7 2UH
-
United Kingdom
Novartis Investigative Site
Recruiting
Oxford, OX3 9DU
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]