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Inebilizumab for autoimmune hepatitis with inadequate response or intolerance to standard of care
ChiCTR2600133852Phase 3Not yet recruiting
- Sponsor
- Renji Hospital
- Start
- Dec 2025
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 1
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Overview
Phase 3, randomised, double-blind trial in autoimmune hepatitis (AIH) comparing Placebo with Inebilizumab 300 mg (2 arms). Primary endpoints: Safety and tolerability of inebilizumab in autoimmune hepatitis and Achieving mHAI <= 3 at Week 52 with stable prednisone dose <= 5 mg/day by Week 52. Planned start Dec 2025; status: not yet recruiting.
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Drugs
inebilizumab
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Conditions
autoimmune hepatitis (AIH)
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