A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorAmgen
About this trial
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).
Eligibility criteria
Qualifiers
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.
Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.
Disqualifiers
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.
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).
Trial design
Treatments tested in this trial
- Inebilizumab
- Placebo
- Standard of Care
Treatment groups
180 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov