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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2020-08-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Autoimmune Hemolytic Anemia Immune Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A - KZR-616 30mg

KZR-616 30mg Subcutaneous (SC) injection weekly for 13 weeks

Group Type EXPERIMENTAL

KZR-616

Intervention Type DRUG

Patients will receive KZR-616 SC once weekly. Patients assigned to Arm A will receive 30 mg for 13 weeks and patients assigned to Arm B will receive 30 mg for 1 week then 45 mg for 12 weeks

Arm B - KZR-616 45mg

KZR-616 30 mg SC injection weekly for 1 dose then 45mg weekly for 12 weeks.

Group Type EXPERIMENTAL

KZR-616

Intervention Type DRUG

Patients will receive KZR-616 SC once weekly. Patients assigned to Arm A will receive 30 mg for 13 weeks and patients assigned to Arm B will receive 30 mg for 1 week then 45 mg for 12 weeks

Interventions

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KZR-616

Patients will receive KZR-616 SC once weekly. Patients assigned to Arm A will receive 30 mg for 13 weeks and patients assigned to Arm B will receive 30 mg for 1 week then 45 mg for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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 primary or secondary AIHA, ITP, or primary Evans syndrome
4. AIHA or ITP disease activity as follows::

1. 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
2. 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.
5. Documented inadequate response on intolerance to ≥1 standard treatment approach for AIHA or ≥2 standard treatment approaches for ITP

Exclusion Criteria

1. 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
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:

1. Estimated glomerular filtration rate (eGFR) \<45 ml/min
2. Absolute neutrophil count (ANC) \<1.5×109/L (1500/mm3)
3. Serum aspartate transaminase (AST), serum alanine transaminase (ALT) or serum alkaline phosphatase \>2.5×ULN
4. Thyroid stimulating hormone if outside of the central laboratory normal range and considered clinically significant
5. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \>1.5×ULN
6. Immunoglobulin G (IgG) \<500 mg/dL
7. For ITP patients only: total bilirubin \>1.5×ULN (3×ULN for patients with documented Gilbert's syndrome).
7. Presence of New York Heart Association Class III or IV heart failure, or uncontrolled blood pressure, or prolonged QT interval
8. Major surgery within 12 weeks before Screening or planned during the study period
9. History of any thrombotic or embolic event within 12 months prior to Screening
10. Clinical evidence of significant unstable or uncontrolled diseases
11. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No