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

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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
Enrollment count 
80 participants
Start date 
Feb 15, 2018
Completion date 
Jul 04, 2025
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
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
Withdrawn
Lakewood Ranch, 34211
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Recruiting
New York, 10029
New York
United States
Novartis Investigative Site
Withdrawn
Durham, 27710
North Carolina
United States
Novartis Investigative Site
Recruiting
Dallas, 75208-2312
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78215
Texas
United States
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1070
-
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
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
Czechia
Novartis Investigative Site
Recruiting
Prague, 12000
-
Czechia
Novartis Investigative Site
Recruiting
Praha 2, 128 02
-
Czechia
Denmark
Novartis Investigative Site
Withdrawn
Copenhagen, DK-2100
-
Denmark
Germany
Novartis Investigative Site
Recruiting
Aachen, 52074
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Halle, 06108
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20246
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
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
Netherlands
Novartis Investigative Site
Withdrawn
Leiden, 2300 RC
-
Netherlands
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Cataluña
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain
Sweden
Novartis Investigative Site
Recruiting
Stockholm, 141 86
SE
Sweden
Novartis Investigative Site
Recruiting
Gothenburg, SE 413 45
-
Sweden
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Lugano, 6900
-
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8091
-
Switzerland
United Kingdom
Novartis Investigative Site
Recruiting
Bradford, BD9 6RJ
West Yorkshire
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

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]