VAY736 for Advanced Cancer
(AMBER Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new medication called VAY736 to help adults with autoimmune hepatitis who haven't responded to or can't tolerate standard treatments. The goal is to see if VAY736 can reduce liver inflammation and improve liver function.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you cannot regularly use medications that harm the liver.
Research Team
Study Director
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
This trial is for individuals with active autoimmune hepatitis (AIH) confirmed by liver biopsy, diagnosed according to international standards, and who haven't fully responded to or can't tolerate standard treatments. It's not for those with advanced cirrhosis, a history of drug-related AIH, recent B-cell depleting therapy use, overlap syndromes like AIH+PBC/PSC, cancer history, or substance abuse.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VAY736 or placebo in a randomized, double-blind, placebo-controlled manner
Follow-up
Participants are monitored for safety and effectiveness after treatment
Subsequent Study Part
A new group of patients will be enrolled to test the efficacy and safety of VAY736 in a parallel group design
Treatment Details
Interventions
- VAY736
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD