A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP

Withdrawn before enrolling · Phase 2

Conditions studied: Autoimmune Hemolytic Anemia, Immune Thrombocytopenia

In brief

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.

Key facts

Study ID

NCT04039477

Run by

Kezar Life Sciences, Inc.

People needed

0

Starts

2020-07-01

Expected to finish

2020-08-05

Last updated by the study team

2020-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• KZR Research Site — Los Angeles, California, United States
• KZR Research Site — San Francisco, California, United States
• KZR Research Site — Jacksonville, Florida, United States
• KZR Research Site — Miami Lakes, Florida, United States
• KZR Research Site — Tampa, Florida, United States
• KZR Research Site — Peoria, Illinois, United States
• KZR Research Site — Boston, Massachusetts, United States
• KZR Research Site — Minneapolis, Minnesota, United States
• KZR-616 Research Site — Rochester, Minnesota, United States
• KZR Research Site — Morristown, New Jersey, United States
• KZR Research Site — The Bronx, New York, United States
• KZR Research Site — Greenville, North Carolina, United States
• KZR Research Site — Cleveland, Ohio, United States
• KZR Research Site — Columbus, Ohio, United States
• KZR Research Site — Webster, Texas, United States
• KZR Research Site — Woolloongabba, Australia
• KZR Research Site — Bologna, Italy
• KZR Research Site — Genova, Italy
• KZR Research Site — Krakow, Poland
• KZR Research Site — Poznan, Poland
• KZR Research Site — Moscow, Russia
• KZR Research Site — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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