A Trial of Inebilizumab in Participants With Autoimmune Hepatitis

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NCT07598825 · readout in 1,806 d

Sponsored by Amgen (industry) · AMGN — their whole pipeline →.

Phase

Phase 3

Status

Not yet recruiting

Study type

Interventional

Design

Randomized · Double · Treatment

Enrollment

180estimated

Sites

Countries

China, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-09-07

estimated

When the study began enrolling

Primary completion

2031-07-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2034-02-11

estimated

The whole study's end, after follow-up

First posted

2026-05-20

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Autoimmune Hepatitis
AIH

Interventions

Drug: Inebilizumab — also filed as AMG 335
Drug: Placebo
Other: Standard of Care

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Interest at Week 26

measured Up to Week 26

Part 2: Number of Participants who Achieved Modified Histologic Activity Index (mHAI) ≤ 3 and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day at Week 78

measured Week 78

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