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New hope for autoimmune hepatitis patients who fail standard treatment

NCT ID NCT03217422

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new biologic drug called VAY736 in 68 adults with autoimmune hepatitis who did not get better with or could not tolerate standard treatments. The goal was to see if VAY736 could safely help normalize liver enzyme levels. Participants received either VAY736 or a placebo, and those on placebo could later switch to the active drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VAY736 (a biologic drug)
What this could lead to
If it works, VAY736 could offer a new treatment option for people with autoimmune hepatitis who don't respond to or can't tolerate standard therapies.
What could go wrong
This is an early-to-mid-stage trial with only 68 participants, so results may not apply to everyone. The drug may not improve liver health or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

68 people

The number who actually took part.

Started

Feb 2018

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune hepatitis

Contacts and locations

Locations

  • Inland Empire Liver Foundation

    Rialto, California, 92377, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABI, Argentina

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2C4, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    Prague, 12000, Czechia

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Hanover, 30625, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0068555, Japan

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 760 8557, Japan

  • Novartis Investigative Site

    Itabashi Ku, Tokyo, 173 8606, Japan

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Novartis Investigative Site

    London, SE5 9RS, United Kingdom

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Novartis Investigative Site

    Nottingham, NG7 2UH, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 9DU, United Kingdom

  • Southern California Research Center

    Coronado, California, 92118, United States

  • St. Lukes Advanced Liver Therapies

    Houston, Texas, 77030, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

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