Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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)

Keywords

Autoimmune Hemolytic Anemia Immune Thrombocytopenia Autoimmune Hemolytic Anemia AIHA Immune Thrombocytopenia ITP Blood disorders Hematology Purpura, Thrombocytopenic, Idiopathic Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Hemolysis KZR-616

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Adult patients must be at least 18 years of age at the time of signing informed consent at Screening
  2. Body Mass Index (BMI) equal to or greater than 18 kg/m2
  3. Have a documented diagnosis of AIHA, ITP, or Evans syndrome
  4. AIHA or ITP disease activity as follows::
  5. ITP: Per 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
  6. AIHA: Hgb ≤10 g/dL and presence of any 2 of the following:
  7. Haptoglobin <lower limit of normal (LLN) ii. Corrected reticulocyte count >upper limit of normal (ULN) iii. LDH >ULN iv. Indirect bilirubin >ULN.
  8. Documented inadequate response on intolerance to ≥1 standard treatment approach for AIHA or ≥2 standard treatment approaches for ITP

You CAN'T join if...

  1. Systemic Lupus Erythematosus 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
  2. History of clinically significant coagulopathy, hereditary thrombocytopenia, anemia, or family history of thrombocytopenia
  3. History of primary immunodeficiency
  4. Use of nonpermitted medications within the specified washout periods prior to screening
  5. Recent serious or ongoing infection, or risk for serious infection
  6. Any of the following laboratory values at Screening:
  7. Estimated glomerular filtration rate (eGFR) <45 ml/min
  8. Absolute neutrophil count (ANC) <1.5×109/L (1500/mm3)
  9. Serum aspartate transaminase (AST), serum alanine transaminase (ALT) or serum alkaline phosphatase >2.5×ULN
  10. Thyroid stimulating hormone if outside of the central laboratory normal range and considered clinically significant
  11. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) >1.5×ULN
  12. Immunoglobulin G (IgG) <500 mg/dL
  13. For ITP patients only: total bilirubin >1.5×ULN (3×ULN for patients with documented Gilbert's syndrome).
  14. Presence of New York Heart Association Class III or IV heart failure, or uncontrolled blood pressure, or prolonged QT interval
  15. Major surgery within 12 weeks before Screening or planned during the study period
  16. History of any thrombotic or embolic event within 12 months prior to Screening
  17. . Clinical evidence of significant unstable or uncontrolled diseases
  18. . 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

Locations

  • KZR Research Site not yet accepting patients
    San Francisco California 94143 United States
  • KZR Research Site not yet accepting patients
    Los Angeles California 90007 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kezar Life Sciences, Inc.
ID
NCT04039477
Phase
Phase 2
Study Type
Interventional
Last Updated