ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

Autoimmune Hepatitis Clinical Trial

— AMBER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03217422
• Other study ID #: CVAY736B2201
• Secondary ID: 2017-001555-32
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: February 15, 2018
• Est. completion date: December 25, 2025

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

VAY736 dose testing; VAY736 efficacy and safety testing.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: December 25, 2025
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

Biological:
• VAY736
VAY736

Other:
• Placebo
Placebo control with conversion to active VAY736

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Belgium	Novartis Investigative Site	Gent
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Czechia	Novartis Investigative Site	Vinohrady
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Wuerzburg
Japan	Novartis Investigative Site	Itabashi ku	Tokyo
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Takamatsu city	Kagawa
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Switzerland	Novartis Investigative Site	Bern
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Oxford
United States	Novartis Investigative Site	Coronado	California
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Rialto	California
United States	Novartis Investigative Site	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Czechia,  Germany,  Japan,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALT (Alanine aminotransferase) normalization	Difference in ALT normalization	Week 24
Secondary	ALT normalization by dose	VAY736 dose-response	Week 24