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Not yet recruiting Phase 3 Interventional

A Trial of Inebilizumab in Participants With Autoimmune Hepatitis

ClinicalTrials.gov ID: NCT07598825

Public ClinicalTrials.gov record NCT07598825. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT07598825
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
180 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 74 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 6, 2026
Primary completion
Jul 29, 2031
Completion
Feb 10, 2034
Last update posted
Aug 13, 2026

2026 – 2034

United States locations

U.S. sites
6
U.S. states
4
U.S. cities
6
Facility City State ZIP Site status
Applied Research Center of Arkansas Little Rock Arkansas 72205
Amicis Research Center Northridge California 91324
Inland Empire Liver Foundation Rialto California 92377
Indiana University Indianapolis Indiana 46202
Methodist Cardiovascular Consultants - Dallas Dallas Texas 75203
American Research Corporation San Antonio Texas 78215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07598825, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07598825 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →