Sickle Cell DiseaseCRIZNCT05334576
Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA
A study testing Crizanlizumab in people with Sickle Cell Disease, run by Andria Ford at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Crizanlizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult participants age 16 and older
- Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype
- Per patient's sickle cell provider, patient has an increased risk of a silent cerebral infarcts according to one of the following criteria:
- Silent cerebral infarcts visualized on FLAIR MRI within previous two years
- Intracranial or extracranial cervical artery vasculopathy
- History of overt ischemic or hemorrhagic stroke and Intolerance and/or failure of other therapies to prevent cerebral infarction
Show all 11Show fewer
- 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).
- Increased risk deemed by other objective laboratory and/or imaging results which have been associated with increased risk of cerebral infarction
- Provide written informed consent.
- Normal hematologic function defined as: WBC > 4x10^9 / L, ANC >1.5x10^9 / L and platelets > 100x10^9 / L
- 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
Who cannot join
- Current chronic transfusion therapy
- Planning for hematopoietic stem cell transplant or cerebral revascularization procedure
- Use of other investigational drug within one year of study participation
- Other medical/neurological/social/substance abuse history that would alter brain MRI findings prospectively
- Inability to return for follow-up
- Contraindication to MRI
Show all 14Show fewer
- Acute bacterial, fungal, or viral infection
- Known HIV, untreated latent tuberculosis (TB), or active hepatitis B or C infection or zoster
- Pregnant and/or breastfeeding. Negative pregnancy test required prior to starting study treatment.
- Known hypersensitivity to one or more of the study agents
- Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug
- Liver function tests (LFT) higher than 3x the upper limit of normal
- Treatment with other monoclonal antibody medications within last 30 days
- Treatment with various forms of anticoagulation within last 30 days, including but not limited to coumadin or direct thrombin inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Andria L. Ford, 314-747-4037, forda@wustl.edu
Nkemdilim Igwe, MS, MSCI, (314) 503-2161, igwe@wustl.edu
About this study
Official title: Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA Novartis Investigator Initiated Trial: CSEG101AUS12T
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.
- Conditions
- Sickle Cell Disease
- Being tested
- Crizanlizumab
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizanlizumabOther
Crizanlizumab 5.0 mg/kg infusions will be administered over 24 months
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Crizanlizumab | Other | Single-arm: Patients with sickle cell disease and increased risk of silent cerebral infarcts Receives: Other: Crizanlizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
New or enlarged silent cerebral infarcts
Occurrence of 'new or enlarged' silent cerebral infarcts between the baseline and 30 month follow-up scan.
Measured: 30 months
Secondary outcomes (1)
Infarct Progression
Change in volume of silent cerebral infarcts between the baseline and 30 month follow-up scan.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Aug 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andria Ford
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Andria Ford, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334576
- Sponsor's protocol ID
- CSEG101AUS12T
- Acronym
- CRIZ
- Status last verified
- Mar 2023
- First submitted
- 30 Nov 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA Novartis Investigator Initiated Trial: CSEG101AUS12T
- ClinicalTrials.gov ID
- NCT05334576
- Acronym / sponsor ID
- CRIZ / CSEG101AUS12T
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Andria FordUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Crizanlizumab | Other | Other: CrizanlizumabSingle-arm: Patients with sickle cell disease and increased risk of silent cerebral infarcts |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Adult participants age 16 and older
- Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype
- Per patient's sickle cell provider, patient has an increased risk of a silent cerebral infarcts according to one of the following criteria:
- Provide written informed consent.
- Normal hematologic function defined as: WBC > 4x10^9 / L, ANC >1.5x10^9 / L and platelets > 100x10^9 / L
Key exclusion criteria (14 listed)
- Current chronic transfusion therapy
- Planning for hematopoietic stem cell transplant or cerebral revascularization procedure
- Use of other investigational drug within one year of study participation
- Other medical/neurological/social/substance abuse history that would alter brain MRI findings prospectively
- Inability to return for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrizanlizumabCrizanlizumab 5.0 mg/kg infusions will be administered over 24 months | Other | Single Arm: Crizanlizumab |
Primary outcome
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.
1 secondary outcome
Infarct Progression
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crizanlizumab in people with Sickle Cell Disease, run by Andria Ford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andria Ford, MD (314-362-7382, forda@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New or enlarged silent cerebral infarcts (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.