Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07598825 | A Trial of Inebilizumab in Participants With Autoimmune Hepatitis | PHASE3 | NOT YET_RECRUITING | 180 | — | — | Sep 7, 2026 | Feb 11, 2034 | May 20, 2026 | - | — |
Participants who met the two outcomes combined will be reported for this endpoint.
| Arm | Type | Description |
|---|---|---|
| Part 1: Inebilizumab | EXPERIMENTAL | Participants will receive inebilizumab as an intravenous (IV) infusion in addition to standard of care (SOC). |
| Part 1: Placebo | EXPERIMENTAL | Participants will receive placebo as an IV infusion in addition to SOC. |
| Part 2: Inebilizumab | EXPERIMENTAL | Participants will receive Inebilizumab as an IV infusion in addition to SOC. |
| Part 2: Placebo | EXPERIMENTAL | Participants will receive placebo as an IV infusion in addition to SOC. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * Signed informed consent. * Age ≥ 18 years or legal adult age within the country, whichever is older and \< 75 years at the time of signing the informed consent. * Participants must have either inadequate response to at least 9 months of SOC or are intolerant to SOC within 6 mo...