68 Participants Needed

VAY736 for Advanced Cancer

(AMBER Trial)

Recruiting at 45 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Prior Safety DataThis treatment has passed at least one previous human 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

SD

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

AIH diagnosed per International Autoimmune Hepatitis Group
My condition did not fully improve or I couldn't tolerate the standard treatment.
Liver biopsy with Ishak modified HAI indicating active AIH

Exclusion Criteria

I haven't used B-cell depleting therapy in the last year or my B-cell count is below 50.
I have had liver inflammation caused by medication.
I have had cancer in any part of my body before.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VAY736 or placebo in a randomized, double-blind, placebo-controlled manner

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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
Trial OverviewThe trial is testing VAY736 in patients with Hepatitis A and Autoimmune Hepatitis. Participants will either receive the actual VAY736 medication or a placebo to compare the effectiveness and safety of this potential new treatment option.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3Experimental Treatment1 Intervention
VAY736 Dose 3
Group II: Arm 2Experimental Treatment1 Intervention
VAY736 Dose 2
Group III: Arm 1Experimental Treatment1 Intervention
VAY736 Dose 1
Group IV: Arm 4Placebo Group1 Intervention
Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD