A Trial of Inebilizumab in Participants With Autoimmune Hepatitis

NCT07598825 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 202402372025-522393-37-00
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Autoimmune hepatitis; AIH; Inebilizumab; AMG 335

Outcome Measures

Primary Outcomes (2)

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

  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

  Participants who met the two outcomes combined will be reported for this endpoint.

  Week 78

Secondary Outcomes (23)

• Part 1: Number of Participants who Achieved Normal Alanine Aminotransferase (ALT) Levels at Week 26

  Week 26

• Part 1: Change from Baseline in ALT Levels at Week 26

  Baseline and Week 26

• Part 1: Maximum Serum Concentration (Cmax) of Inebilizumab

  Up to Week 26

• Part 1: Area Under the Serum Concentration-time Curve (AUC) of Inebilizumab

  Up to Week 26

• Part 1: Change from Baseline in Peripheral B Cell Counts at Week 26

  Baseline and Week 26

Study Arms (4)

Part 1: Inebilizumab

EXPERIMENTAL

Participants will receive inebilizumab as an intravenous (IV) infusion in addition to standard of care (SOC).

Drug: Inebilizumab; Other: Standard of Care

Part 1: Placebo

EXPERIMENTAL

Participants will receive placebo as an IV infusion in addition to SOC.

Drug: Placebo; Other: Standard of Care

Part 2: Inebilizumab

EXPERIMENTAL

Participants will receive Inebilizumab as an IV infusion in addition to SOC.

Drug: Inebilizumab; Other: Standard of Care

Part 2: Placebo

EXPERIMENTAL

Participants will receive placebo as an IV infusion in addition to SOC.

Drug: Placebo; Other: Standard of Care

Interventions

Inebilizumab DRUG

Inebilizumab will be administered as an IV infusion.

Also known as: AMG 335

Part 1: Inebilizumab; Part 2: Inebilizumab

Placebo DRUG

Placebo will be administered as IV infusion.

Part 1: Placebo; Part 2: Placebo

Standard of Care OTHER

Standard of Care

Part 1: Inebilizumab; Part 1: Placebo; Part 2: Inebilizumab; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age ≥ 18 years or legal adult age within the country, whichever is older and \< 75 years at the time of signing the informed consent.
• Participants must have either inadequate response to at least 9 months of SOC or are intolerant to SOC within 6 months of screening. Inadequate response to SOC treatment is defined as ALT ≥ 2 upper limit of normal (ULN) at screening after at least 9 months of SOC, including prednisone (or equivalent) \> 5 mg/day and at least one conventional steroid sparing agent at guideline-concordant target or highest appropriate dose, that is azathioprine (AZA) or 6-mercaptopurine (6-MP) at appropriate weight-based dosing (typically up to 2 mg/kg/day AZA or 1 mg/kg/day 6-MP) or mycophenolate (MMF) up to 2 g/day, as judged appropriate by the investigator and documented in the medical record.
• Intolerance to SOC treatment is defined as any clinically significant adverse event related to treatment that results in discontinuation of the medication or prevents dose optimization necessary to achieve or maintain biochemical response, as determined by the Principal Investigator (PI). Intolerance applies to GCs, AZA, 6-MP, or MMF. Presence of one or more clinically significant adverse effects attributed to SOC include but not limited to side effects that, in the opinion of the investigator, compromise participant's safety or quality of life, exacerbate comorbid conditions, or render continued use medically inappropriate.
• Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.
• Participant must have a biopsy proven definitive diagnosis of AIH according to simplified diagnostic criteria (score ≥ 7). Liver biopsy should be obtained within 90 days prior to randomization. Participants must have a mHAI score ≥ 5 in the biopsy.
• Participant should be on:
• No increase in GC dose during the 28 days immediately preceding whichever biopsy is designated as the baseline sample-historical or screening-and the dose post biopsy must remain unchanged through the day of randomization AND
• Stable maximum tolerated doses of AZA or 6-MP for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons OR
• Stable maximum tolerated doses of MMF/mycophenolic acid (MPA) for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons.
• Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.

You may not qualify if:

• Diagnosis of definitive overlap autoimmune liver or rheumatologic syndrome with autoimmune hepatitis (eg, AIH + primary biliary cholangitis \[PBC\], AIH + primary sclerosing cholangitis \[PSC\], AIH related to Systemic Lupus Erythematosus, etc) where established overlap criteria are met.
• Acute liver failure (ALF) at screening (e.g., acute hepatic dysfunction with coagulopathy and any degree of encephalopathy) in the investigator's judgment.
• Participant has known history of:
• Allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.
• Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions (antipyretic such as paracetamol/acetaminophen or equivalent, diphenhydramine or equivalent, and methylprednisolone or equivalent).
• Active malignancy or history of malignancy that was active within the last 10 years, except as follows:
• In situ carcinoma of the cervix treated with apparent success with curative therapy for \> 12 months prior to screening
• Curatively treated breast ductal carcinoma in situ
• Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for \> 12 months prior to screening
• Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent \> 3 years prior to screening and without known recurrence or current treatment
• Thyroid cancer for which complete surgical resection has been performed within 5 years with well-differentiated histology (papillary thyroid carcinoma or follicular thyroid carcinoma) and there is no evidence of active disease.
• Known positive test for human immunodeficiency virus (HIV) infection. Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
• Presence or history of viral hepatitis infection:
• Positive test for, or prior treatment for, hepatitis B. A positive test for hepatitis B is detection of either:
• Positive for hepatitis B surface antigen (HBsAg) OR

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

inebilizumab; Standard of Care

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): July 30, 2031
• Study Completion (Estimated): February 11, 2034
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.