drugset / Trial / NCT04039477
A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 2 randomized, dose-blind, multicenter study designed to evaluate the safety, tolerability, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) of treatment with KZR-616 in patients with active Autoimmune Hemolytic Anemia or Immune Thrombocytopenia.
Timeline
- Start
- 2020-07
- Primary completion
- 2020-08-05
- Completion
- 2020-08-05
Outcome
Outcome not reported
Stopped (Enrollment): “Clinical trial activity slowdown due to COVID-19 pandemic, high screen fail rate, and lack of enrollment led to the decision to withdraw the MARINA study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zetomipzomib | Protein / enzyme biologic | 30 mg | Subcutaneous |
| Subject | zetomipzomib | Protein / enzyme biologic | 45 mg | Subcutaneous |