RecruitingAutoimmune HepatitisAIH
A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
Eligible age
18–74 yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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).
Sponsor: Amgen
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
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
Where it's recruiting
Arkansas
Little Rock
California
Rialto · Valencia
Florida
Miami Lakes
Indiana
Indianapolis
Texas
Dallas · San Antonio
Source: ClinicalTrials.gov · NCT07598825 · last updated 2026-10-16