ADCC Mediated B-Cell dEpletion and BAFF-R Blockade
AMBER
A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis
2 other identifiers
interventional
68
10 countries
28
Brief Summary
VAY736 dose testing; VAY736 efficacy and safety testing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2018
Longer than P75 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2025
CompletedFebruary 19, 2026
February 1, 2026
5.9 years
July 12, 2017
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ALT (Alanine aminotransferase) normalization
Difference in ALT normalization
Week 24
Secondary Outcomes (1)
ALT normalization by dose
Week 24
Study Arms (4)
Arm 1
EXPERIMENTALVAY736 Dose 1
Arm 2
EXPERIMENTALVAY736 Dose 2
Arm 3
EXPERIMENTALVAY736 Dose 3
Arm 4
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Southern California Research Center
Coronado, California, 92118, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
St. Lukes Advanced Liver Therapies
Houston, Texas, 77030, United States
Novartis Investigative Site
CABA, Buenos Aires, C1056ABI, Argentina
Novartis Investigative Site
CABA, C1181ACH, Argentina
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Edmonton, Alberta, T6G 2B7, Canada
Novartis Investigative Site
Toronto, Ontario, M5G 2C4, Canada
Novartis Investigative Site
Montreal, Quebec, H2X 1R9, Canada
Novartis Investigative Site
Prague, 12000, Czechia
Novartis Investigative Site
Würzburg, Bavaria, 97080, Germany
Novartis Investigative Site
Aachen, 52074, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Sapporo, Hokkaido, 0068555, Japan
Novartis Investigative Site
Takamatsu, Kagawa-ken, 760 8557, Japan
Novartis Investigative Site
Itabashi Ku, Tokyo, 173 8606, Japan
Novartis Investigative Site
Barcelona, 08036, Spain
Novartis Investigative Site
Madrid, 28009, Spain
Novartis Investigative Site
Madrid, 28046, Spain
Novartis Investigative Site
Bern, 3010, Switzerland
Novartis Investigative Site
Birmingham, West Midlands, B15 2TH, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP, United Kingdom
Novartis Investigative Site
Nottingham, NG7 2UH, United Kingdom
Novartis Investigative Site
Oxford, OX3 9DU, United Kingdom
Related Publications (2)
Cholankeril G, Vierling JM. The clinical imperative of a complete biochemical response to immunosuppression in autoimmune hepatitis: Close is not good enough! Hepatology. 2024 Mar 1;79(3):529-531. doi: 10.1097/HEP.0000000000000597. Epub 2023 Sep 18. No abstract available.
PMID: 37722131DERIVEDChung YY, Rahim MN, Heneghan MA. Autoimmune hepatitis and pregnancy: considerations for the clinician. Expert Rev Clin Immunol. 2022 Apr;18(4):325-333. doi: 10.1080/1744666X.2022.2044307. Epub 2022 Mar 2.
PMID: 35179437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind, placebo-controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2017
First Posted
July 14, 2017
Study Start
February 15, 2018
Primary Completion
December 28, 2023
Study Completion
December 17, 2025
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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