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