ADCC Mediated B-Cell dEpletion and BAFF-R Blockade (AMBER)

February 18, 2026 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis

VAY736 dose testing; VAY736 efficacy and safety testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, placebo-controlled, double-blind dose range study in autoimmune hepatitis. The study population consists of female and male adult autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care. The diagnosis of autoimmune hepatitis has to fulfill the IAIHG criteria and must be confirmed by liver histology.

Patients will be randomly assigned to different doses of VAY736 or placebo. The primary analysis is planned at 24 weeks. A subsequent study part will then test the efficacy and safety of VAY736 in a parallel group design. For this part of the trial a new group of autoimmune hepatitis patients will be enrolled.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1181ACH
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1056ABI
        • Novartis Investigative Site
  • Belgium
      • Ghent, Belgium, 9000
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 1R9
        • Novartis Investigative Site
  • Czechia
      • Prague, Czechia, 12000
        • Novartis Investigative Site
  • Germany
      • Aachen, Germany, 52074
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Hanover, Germany, 30625
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Novartis Investigative Site
  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0068555
        • Novartis Investigative Site
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760 8557
        • Novartis Investigative Site
    • Tokyo
      • Itabashi Ku, Tokyo, Japan, 173 8606
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08036
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novartis Investigative Site
      • Oxford, United Kingdom, OX3 9DU
        • Novartis Investigative Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Novartis Investigative Site
  • United States
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • St. Lukes Advanced Liver Therapies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. AIH diagnosed per International Autoimmune Hepatitis Group
  2. Liver biopsy with Ishak modified HAI indicating active AIH
  3. Incomplete response to OR intolerance of standard therapy (per AASLD)

Key Exclusion Criteria

  1. 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
  2. Required regular use of medications with known hepatotoxicity
  3. Decompensated cirrhosis
  4. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
  5. Drug related AIH at screening or a history of drug related AIH.
  6. History of drug abuse or unhealthy alcohol use
  7. History of malignancy of any organ system
  8. Pregnant or nursing (lactating) women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 4
Placebo
Other: Placebo
Placebo control with conversion to active VAY736
Experimental: Arm 1
VAY736 Dose 1
Biological: VAY736
VAY736
Experimental: Arm 2
VAY736 Dose 2
Biological: VAY736
VAY736
Experimental: Arm 3
VAY736 Dose 3
Biological: VAY736
VAY736

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALT (Alanine aminotransferase) normalization
Time Frame: Week 24
Difference in ALT normalization
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALT normalization by dose
Time Frame: Week 24
VAY736 dose-response
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Study Director, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

December 28, 2023

Study Completion (Actual)

December 17, 2025

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAY736B2201
  • 2023-508859-39-00 (Registry Identifier: EU CT NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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