A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP (NCT04039477) | Clinical Trial Compass
WithdrawnPhase 2
A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
Stopped: Clinical trial activity slowdown due to COVID-19 pandemic, high screen fail rate, and lack of enrollment led to the decision to withdraw the MARINA study.
United States0Started 2020-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
✓. Documented inadequate response on intolerance to ≥1 standard treatment approach for AIHA or ≥2 standard treatment approaches for ITP
Exclusion criteria
✕. 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
✕
What they're measuring
1
Mean change from Baseline to Week 13 in hematologic parameters of interest in evaluable patients (Hgb for AIHA; Platelets [PLT] for ITP)