MERCURY (Monoclonal inEbilizumab Randomized placebo- Controlled aUtoimmune hepatitis Research studY)

This is a randomized, multicenter, double-blind, phase 2/3 study to evaluate the efficacy and safety of inebilizumab in participants with active autoimmune hepatitis (AIH) who are inadequately responding and/or are intolerant to standard of care (SOC). The study consists of 2 parts, a phase 2 dose confirmation and safety part (Part 1) and an efficacy evaluating phase 3 (Part 2). The combined data from both Part 1 and Part 2 will be included in the primary analysis. The target population includes adults who have a definitive diagnosis of AIH and have either inadequate response to at least 9 months of SOC or is intolerant to SOC within 6 months of screening. The Primary objective for Part 1 is to evaluate the safety and tolerability of inebilizumab in participants with AIH. The Primary objective of Part 2 is to evaluate the efficacy of inebilizumab on AIH disease activity and glucocorticoid (GC) use in the management of AIH.

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: 99 years or below
• Gender: All