A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study Of Inebilizumab In Participants With Autoimmune Hepatitis

Autoimmune Hepatitis (AIH)

Treatment-emergent adverse events, treatment-emergent serious adverse events, and treatment-emergent adverse events of interest during the first 26 weeks of randomized controlled treatment period, Part 2: Achieving modified histologic activity index (mHAI) ≤ 3 at CCI and stable prednisone dose (or equivalent) ≤5 mg/day by CCI

Achieving normal ALT at week 26, Change from baseline in ALT at week 26, Serum concentration of inebilizumab and noncompartmental PK parameters (eg, maximum serum concentration [Cmax] and area under the serum concentration-time curve [AUC]), Changes from baseline in peripheral B cell counts, including total B cells and B cell subsets during the 26 weeks of randomized controlled treatment period, Part 2: Achieving sustained normal ALT defined as achieving normal ALT in the 3 consecutive visits CCI including and stable prednisone dose (or equivalent) ≤ 5 mg/day by CCI, Achieving normal ALT at CCI mHAI ≤ 3 at CCI and stable prednisone dose (or equivalent) ≤ 5, Achieving stable prednisone dose (or equivalent) ≤ 5 mg/day by CCI, Achieving flare-free stable GC-free (0 mg) normalization of ALT by CCI, Cumulative GC dose per participant for AIH during RCP CCI, Antidrug Antibodies (ADA) directed against inebilizumab during the 78-Week randomized controlled treatment period, Serum concentration of inebilizumab and noncompartmental PK parameters (eg, Cmax and AUC), Treatment-emergent adverse events, treatment-emergent serious adverse events, and treatment-emergent adverse events of interest, Change from baseline of GC toxicity index score at CCI, •Achieving normal ALT and stable GC free 0 mg  •Time to persistently normal ALT defined as the first occurrence of normal ALT in at least 2 consecutive visits  and achieving on stable prednisone or equivalent ≤ 5 mg/day through CCI Change in baseline in ALT, IgG, AST, and mHAI •Achieving normal ALT and IgG  •Achieving mHAI ≤3

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