drugset / Trial / NCT05569759
A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This was a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis received zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allowed participants to receive zetomipzomib (KZR-616) for an additional 24 weeks of treatment.
Timeline
- Start
- 2023-05-23
- Primary completion
- 2025-04-30
- Completion
- 2025-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zetomipzomib | Protein / enzyme biologic | 60 mg | Subcutaneous |