Status:
WITHDRAWN
A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
Lead Sponsor:
Kezar Life Sciences, Inc.
Conditions:
Autoimmune Hemolytic Anemia
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 patie...
Eligibility Criteria
Inclusion
- Adult patients must be at least 18 years of age at the time of signing informed consent at Screening
- Body Mass Index (BMI) equal to or greater than 18 kg/m2
- Have a documented diagnosis of primary or secondary AIHA, ITP, or primary Evans syndrome
- AIHA or ITP disease activity as follows::
- ITP: Per central or local laboratory assessments on 2 separate occasions ≥7 days apart during Screening, a mean Platelet (PLT) ≤30×109/L with no individual PLT \>35×109/L; or for those patients receiving a constant dose of permitted treatments for ITP: a mean PLT \<50×109/L, with no count \>55×109/L
- AIHA: Hgb ≤10 g/dL and presence of any 2 of the following:
- i. Haptoglobin \<lower limit of normal (LLN) ii. Corrected reticulocyte count \>upper limit of normal (ULN) iii. LDH \>ULN iv. Indirect bilirubin \>ULN.
- Documented inadequate response on intolerance to ≥1 standard treatment approach for AIHA or ≥2 standard treatment approaches for ITP
Exclusion
- Systemic Lupus Erythematosus (SLE) with confirmed anti-phospholipid antibody syndrome, the presence of positive lupus anti-coagulant test, moderate-high titer anti-cardiolipin IgG or IgM or moderate-high titer anti-beta2-globuilin IgG or IgM or severe central nervous system involvement
- History of clinically significant coagulopathy, hereditary thrombocytopenia, anemia, or family history of thrombocytopenia
- History of primary immunodeficiency
- Use of nonpermitted medications within the specified washout periods prior to screening
- Recent serious or ongoing infection, or risk for serious infection
- Any of the following laboratory values at Screening:
- Estimated glomerular filtration rate (eGFR) \<45 ml/min
- Absolute neutrophil count (ANC) \<1.5×109/L (1500/mm3)
- Serum aspartate transaminase (AST), serum alanine transaminase (ALT) or serum alkaline phosphatase \>2.5×ULN
- Thyroid stimulating hormone if outside of the central laboratory normal range and considered clinically significant
- International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \>1.5×ULN
- Immunoglobulin G (IgG) \<500 mg/dL
- For ITP patients only: total bilirubin \>1.5×ULN (3×ULN for patients with documented Gilbert's syndrome).
- Presence of New York Heart Association Class III or IV heart failure, or uncontrolled blood pressure, or prolonged QT interval
- Major surgery within 12 weeks before Screening or planned during the study period
- History of any thrombotic or embolic event within 12 months prior to Screening
- Clinical evidence of significant unstable or uncontrolled diseases
- Any active or suspected malignancy or history of documented malignancy within the last 5 years before Screening, except appropriately excised and cured cervical carcinoma in situ or basal or squamous cell carcinoma of the skin, or non-muscle invasive bladder cancer
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04039477
Start Date
July 1 2020
End Date
August 5 2020
Last Update
August 7 2020
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
KZR Research Site
Los Angeles, California, United States, 90007
2
KZR Research Site
San Francisco, California, United States, 94143
3
KZR Research Site
Jacksonville, Florida, United States, 32224
4
KZR Research Site
Miami Lakes, Florida, United States, 33014