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

Condition studied

Autoimmune Hepatitis (AIH)

Investigational medicinal product(s)

Eligibility

Primary endpoint

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

Endpoint detail

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