Trials / Withdrawn
WithdrawnNCT04039477
A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
A Phase 2 Randomized, Dose-blind, Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Kezar Life Sciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KZR-616 | Patients will receive KZR-616 SC once weekly. Patients assigned to Arm A will receive 30 mg for 13 weeks and patients assigned to Arm B will receive 30 mg for 1 week then 45 mg for 12 weeks |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2020-08-05
- Completion
- 2020-08-05
- First posted
- 2019-07-31
- Last updated
- 2020-08-07
Locations
22 sites across 5 countries: United States, Australia, Italy, Poland, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04039477. Inclusion in this directory is not an endorsement.