Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
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) of 18 to 40 kg/m2
  3. Have a documented diagnosis of AIHA or ITP as follows:
  4. AIHA or ITP disease activity as follows:
  5. ITP: Per central 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. Absolute 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. Presence of another autoimmune or autoinflammatory disease
  2. History of 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 outside of the central laboratory normal range
  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-616 Research Site not yet accepting patients
    San Francisco California 94143 United States
  • KZR-616 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