Inebilizumab for Autoimmune Hepatitis

(MERCURY Trial)

Not yet recruiting at 11 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Amgen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The main objectives of this trial are to evaluate the safety and tolerability of inebilizumab in participants with autoimmune hepatitis (AIH) (Part 1) and to evaluate the efficacy of inebilizumab on AIH disease activity and glucocorticoid (GC) use in the management of AIH (Part 2).

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to under 75 with autoimmune hepatitis who haven't responded well to standard treatments or can't tolerate them. Participants must have active disease, a recent liver biopsy confirming diagnosis, and be on stable medication doses. They also need to use contraception during and after the study.

Inclusion Criteria

* Signed informed consent.
* Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.
I have a recent liver biopsy confirming autoimmune hepatitis with a high activity score.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Inebilizumab

Trial Overview

The study compares inebilizumab (an experimental drug) against a placebo, both given alongside standard care for autoimmune hepatitis. The goal is to see if inebilizumab is safe and helps control the disease better than current treatments.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Part 2: PlaceboExperimental Treatment2 Interventions
Group II: Part 2: InebilizumabExperimental Treatment2 Interventions
Group III: Part 1: PlaceboExperimental Treatment2 Interventions
Group IV: Part 1: InebilizumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London