Amgen
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).
This study will consist of a screening period (up to 56 days), a randomized controlled treatment period (78 weeks), an optional open label period (OLP) up to 78 weeks (or until potential availability of the marketed drug) for eligible participants who complete the treatment period, and a safety follow-up (SFU) period up to 78 weeks. The randomized controlled treatment period will be divided in 2 parts, a phase 2 dose confirmation and safety part (Part 1) and an efficacy evaluating phase 3 (Part 2). Part 1 will conclude when the last Part 1 participant has had the opportunity to complete the W…
Inclusion Criteria: * 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 approp…
Inebilizumab will be administered as an IV infusion.
Placebo will be administered as IV infusion.
Standard of Care