A Trial of Inebilizumab in Participants With Autoimmune Hepatitis

Sponsor
Amgen
Study ID
NCT07598825
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • AIH
  • Autoimmune Hepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Inebilizumab — DRUG
    Inebilizumab will be administered as an IV infusion.
  • Placebo — DRUG
    Placebo will be administered as IV infusion.
  • Standard of Care — OTHER
    Standard of Care

Study Details

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).

Key Dates

Start date
Sep 7, 2026
Status verified
Apr 2026
Primary completion
Jul 30, 2031
Completion
Feb 11, 2034

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Inebilizumab
    Participants will receive inebilizumab as an intravenous (IV) infusion in addition to standard of care (SOC).
  • Experimental: Part 1: Placebo
    Participants will receive placebo as an IV infusion in addition to SOC.
  • Experimental: Part 2: Inebilizumab
    Participants will receive Inebilizumab as an IV infusion in addition to SOC.
  • Experimental: Part 2: Placebo
    Participants will receive placebo as an IV infusion in addition to SOC.

Primary Outcome Measure

Part 1: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Interest at Week 26 [ Time Frame: Up to Week 26 ]

Central Contacts

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