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A Trial of Inebilizumab in Participants With Autoimmune Hepatitis

NCT07598825 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-20

No results posted yet for this study

Summary

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).

Conditions

  • Autoimmune Hepatitis
  • AIH

Interventions

DRUG

Inebilizumab

Inebilizumab will be administered as an IV infusion.

DRUG

Placebo

Placebo will be administered as IV infusion.

OTHER

Standard of Care

Standard of Care

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-07
Primary Completion
2031-07-30
Completion
2034-02-11
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07598825 on ClinicalTrials.gov