What side effects are associated with this type of intervention?

Common treatments for Autoimmune Hepatitis include corticosteroids like prednisone and immunosuppressants such as azathioprine. These treatments can cause side effects such as weight gain, diabetes, osteoporosis, hypertension, and increased risk of infections. Monoclonal antibodies targeting the BAFF receptor, like VAY736, are being studied for their efficacy and safety. Similar treatments, such as rituximab, have been associated with infusion reactions, serum-sickness-like reactions, and increased risk of infections. It is important to monitor patients closely for these potential side effects.

What prior FDA approvals exist?

There are no specific FDA-approved monoclonal antibodies targeting the BAFF receptor for the treatment of Autoimmune Hepatitis. However, treatments for autoimmune conditions often include biologic agents such as rituximab, which targets CD20 on B-cells, and belimumab, which targets the B-cell activating factor (BAFF). These agents are used in conditions like systemic lupus erythematosus and rheumatoid arthritis, which share some immunologic pathways with Autoimmune Hepatitis.

What other types of research exist?

Promising novel alternatives to VAY736 for Autoimmune Hepatitis patients in 2024 include: <ol> <li>Obinutuzumab: A monoclonal antibody that induces superior B-cell cytotoxicity and has shown efficacy in autoimmune conditions like systemic lupus erythematosus.</li> <li></li> </ol> Daratumumab: Another monoclonal antibody targeting CD38, which has demonstrated rapid and deep hematologic responses in conditions like AL amyloidosis and could be beneficial for autoimmune hepatitis. 3. Baricitinib: An oral Janus kinase (JAK) inhibitor that has shown promise in treating systemic lupus erythematosus and may offer a novel mechanism of action for autoimmune hepatitis.

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Monoclonal Antibodies

VAY736 for Advanced Cancer (AMBER Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Drug related AIH at screening or a history of drug related AIH

History of malignancy of any organ system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, generally such interventions may cause immune system changes leading to increased infection risk; reactions at injection sites; potential liver enzyme alterations; fatigue; and possibly allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had liver inflammation caused by medication.

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I have had cancer in any part of my body before.

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I regularly use medication known to affect the liver.

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My liver is severely damaged and cannot function properly.

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I have been diagnosed with overlap syndrome, including AIH.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ALT (Alanine aminotransferase) normalization

Secondary study objectives

ALT normalization by dose

Side effects data

From 2018 Phase 2 trial • 27 Patients • NCT02149420

75%

Infusion related reaction

33%

Nasopharyngitis

17%

Headache

Fatigue

Back pain

Rash

Cystitis

Conjunctivitis

Sinusitis

Iron deficiency anaemia

Myalgia

Gastroenteritis

Gastrointestinal infection

Influenza

100%

80%

60%

40%

20%

Study treatment Arm

VAY736 10mg/kg

VAY736 3mg/kg

Placebo

Open Label VAY736 10mg/kg

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VAY736

2014

Completed Phase 3

~790

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autoimmune Hepatitis (AIH) include corticosteroids and immunosuppressants like azathioprine, which work by reducing inflammation and suppressing the immune system to prevent it from attacking liver cells. Monoclonal antibodies, such as those targeting the BAFF receptor (like VAY736), represent a newer approach by specifically depleting B-cells or blocking their survival signals, thereby reducing the production of autoantibodies that contribute to liver damage. This targeted mechanism is crucial for AIH patients as it offers a more precise treatment option with potentially fewer side effects compared to broad immunosuppression.