CompletedPhase 2/3

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

United States, Argentina, Belgium68 participantsStarted 2018-02-15

Plain-language summary

VAY736 dose testing; VAY736 efficacy and safety testing.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. AIH diagnosed per International Autoimmune Hepatitis Group
. Liver biopsy with Ishak modified HAI indicating active AIH
. Incomplete response to OR intolerance of standard therapy (per AASLD)

Exclusion criteria

. 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
. Required regular use of medications with known hepatotoxicity
. Decompensated cirrhosis
. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
. Drug related AIH at screening or a history of drug related AIH.
. History of drug abuse or unhealthy alcohol use
. History of malignancy of any organ system
. Pregnant or nursing (lactating) women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ALT (Alanine aminotransferase) normalization

Timeframe: Week 24

Trial details

NCT IDNCT03217422

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-28

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