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ADCC Mediated B-Cell dEpletion and BAFF-R Blockade — AMBER  

Autoimmune Hepatitis Clinical Trial

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

Clinical Trial Summary

VAY736 dose testing; VAY736 efficacy and safety testing.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03217422
Study type Interventional
Source Novartis
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date February 15, 2018
Completion date December 25, 2025
View Details
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