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Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA (CRIZ)

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ClinicalTrials.gov Identifier: NCT05334576
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : March 6, 2023
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Andria Ford, Washington University School of Medicine

Study Description
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Brief Summary:
In this prospective, single-arm, open-label, imaging and treatment study, the investigator will test the hypothesis that crizanlizumab will prevent the progression of silent cerebral infarcts in patients with sickle cell disease. Study participants will undergo brain MRI before initiation of crizanlizumab and at 6 and 30 months after starting crizanlizumab infusions. The crizanlizumab cohort will be compared to a matched, observational cohort of patients not receiving crizanlizumab.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Crizanlizumab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Crizanlizumab (SEG101) at 5.0 mg/kg dose administered over two years per standard of care in patients with sickle cell disease and silent cerebral infarcts.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA Novartis Investigator Initiated Trial: CSEG101AUS12T
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Single Arm: Crizanlizumab
Single-arm: Patients with sickle cell disease and increased risk of silent cerebral infarcts
 Other: Crizanlizumab
Crizanlizumab 5.0 mg/kg infusions will be administered over 24 months


Outcome Measures
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Primary Outcome Measures :
  1. New or enlarged silent cerebral infarcts [ Time Frame: 30 months ]
    Occurrence of 'new or enlarged' silent cerebral infarcts between the baseline and 30 month follow-up scan.


Secondary Outcome Measures :
  1. Infarct Progression [ Time Frame: 30 months ]
    Change in volume of silent cerebral infarcts between the baseline and 30 month follow-up scan.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult participants age 16 and older
  2. Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype

  3. Per patient's sickle cell provider, patient has an increased risk of a silent cerebral infarcts according to one of the following criteria:

    1. Silent cerebral infarcts visualized on FLAIR MRI within previous two years
    2. Intracranial or extracranial cervical artery vasculopathy
    3. History of overt ischemic or hemorrhagic stroke and Intolerance and/or failure of other therapies to prevent cerebral infarction
    4. Increased severity of sickle cell disease including having between 2 and 10 sickle cell-related pain crises within the preceding 12 months as determined by medical history or by patient's recall (crises should include the occurrence of appropriate symptoms, a visit to a specific medical facility and/or health care professional, and receipt of pain medication).
    5. Increased risk deemed by other objective laboratory and/or imaging results which have been associated with increased risk of cerebral infarction
  4. Provide written informed consent.
  5. Normal hematologic function defined as: WBC > 4x10^9 / L, ANC >1.5x10^9 / L and platelets > 100x10^9 / L
  6. Females of childbearing potential (FCBP) must agree to refrain from becoming pregnant while on crizanlizumb and for 3 months after discontinuation from crizanlizumab, and must agree to use adequate contraception including hormonal contraception, (i.e. birth control pills, etc.), barrier method contraception (i.e. condoms), or abstinence during the time-frame

Exclusion Criteria:

  1. Current chronic transfusion therapy
  2. Planning for hematopoietic stem cell transplant or cerebral revascularization procedure
  3. Use of other investigational drug within one year of study participation
  4. Other medical/neurological/social/substance abuse history that would alter brain MRI findings prospectively
  5. Inability to return for follow-up
  6. Contraindication to MRI
  7. Acute bacterial, fungal, or viral infection
  8. Known HIV, untreated latent tuberculosis (TB), or active hepatitis B or C infection or zoster
  9. Pregnant and/or breastfeeding. Negative pregnancy test required prior to starting study treatment.
  10. Known hypersensitivity to one or more of the study agents
  11. Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug
  12. Liver function tests (LFT) higher than 3x the upper limit of normal
  13. Treatment with other monoclonal antibody medications within last 30 days
  14. Treatment with various forms of anticoagulation within last 30 days, including but not limited to coumadin or direct thrombin inhibitors
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05334576


Contacts
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Contact: Andria Ford, MD 314-362-7382 forda@wustl.edu
Contact: Nkemdilim N Igwe, MS 314-503-2161 igwe@wustl.edu

Locations
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United States, Missouri
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Andria L. Ford    314-747-4037    forda@wustl.edu   
Contact: Nkemdilim Igwe, MS, MSCI    (314) 503-2161    igwe@wustl.edu   
Sponsors and Collaborators
Andria Ford
Novartis Pharmaceuticals
More Information
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Responsible Party: Andria Ford, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT05334576    
Other Study ID Numbers: CSEG101AUS12T
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cerebral Infarction
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Infarction
Ischemia
Pathologic Processes
 Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases