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New drug combo could tame autoimmune hepatitis and cut steroid use

NCT ID NCT06381453

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding belimumab to standard therapy can better control autoimmune hepatitis, a chronic liver disease. About 48 adults with active or stable disease will receive weekly injections for 72 weeks. The goal is to reduce liver inflammation and lower the need for steroids or other immune-suppressing drugs.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 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.

Inclusion Criteria: * Ability to provide written informed consent * Established clinical diagnosis of autoimmune hepatitis for at least 6 months * Participant and clinician consent to follow AIH study therapy guidance for the duration of the open label clinical trial. Group A: * ALT \> 1.5 x ULN in the absence of clinical evidence or concern for alternative etiology, and assessed by the investigator as related to active AIH using standard of care evaluation. * Ongoing therapy with corticosteroids, and/or non-biologic immunosuppressants (AZA, MMF, MP) at a stable dosage for 4 weeks prior to screening Group B: * Patients with normal ALT and normal IgG concentration * Ongoing therapy with single agent immunosuppression or immunosuppression with low dose Prednisone (10mg or less or budesonide 6mg or less)) alongside a second line agent (azathioprine, MMF, MP) * Fibroscan showing liver stiffness of \< 16kPa. Exclusion Criteria: * Primary liver disease other than AIH * High probability of NAFLD as assessed by the investigator. * ALT \>15 x ULN * Patients positive for HBsAg or HBcAb and/or Hepatitis C RNA * Prior use if corticosteroid \>15mg daily * A positive pregnancy test and/or breast feeding * The presence of advanced liver disease as defined by any of: 1. Total Bilirubin \>3 x ULN. 2. Platelet count \<100 x109/L. 3. INR \>1.5 * Live vaccines within 30 days prior to screening or at any time during the study * The use of other biologics including TNF inhibitors, abatacept, or tocilizumab within the washout period

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • G.I Research Institute

    RECRUITING

    Vancouver, British Columbia, Canada

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, Canada

  • McMaster University

    RECRUITING

    Hamilton, Ontario, Canada

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of Calgary

    RECRUITING

    Calgary, Alberta, Canada

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