Back to resultsA Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism (SPARTAN)
Primary Purpose
Priapism
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
crizanlizumab
Sponsored by
About this trial
This is an interventional treatment trial for Priapism focused on measuring Priapism, sickle cell disease, SCD, crizanlizumab, P-selectin, SEG101, monoclonal antibody, prolonged erection, painful erection
Eligibility Criteria
Inclusion criteria
- Male patients aged 16 years and above
- Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography. All SCD genotypes are eligible (HbSS, HbSβ0, HbSC, HbSβ+, and others)
- Experienced 4 or more priapic events (unwanted erection lasting at least 60 minutes) over the 14 weeks preceding study participation
- Experienced at least 3 priapic events (unwanted erection lasting at least 60 minutes) during the 12 week screening period with at least 1 event occurring within 4 weeks prior to the first treatment.
- If receiving hydroxyurea/hydroxycarbamide or L-glutamine or erythropoietin stimulating agent, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
- If receiving prophylactic treatment for priapism, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
- Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
Exclusion criteria:
- Had penile prosthetic implants or shunts or any other surgical procedure on the penis
- Took drugs/medications that may induce priapism over the 14 weeks preceding study entry
- Received leuprolide acetate (Lupron) within 3 months before pre-screening.
- Had an erection lasting more than 12 hours over the 14 week preceding study entry
- Had an erection lasting more than 12 hours during the 12 weeks of the screening period
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- University of Alabama .
- University of Connecticut Health Center .
- Childrens National Hospital SC
- Foundation for Sickle Cell Disease Research
- Emory University School of Medicine/Winship Cancer Institute .
- Childrens Healthcare of Atlanta .Recruiting
- Georgia Health Sciences University .Recruiting
- LSU Medical Center
- Childrens Hospital Boston
- Jacobi Medical CenterRecruiting
- Montefiore Medical Center .
- NYC H Hospital Queens Cancer CenterRecruiting
- Levine Cancer Insitute Carolinas Healthcare SystemRecruiting
- Duke University Medical Center .
- Brody School of Medicine .
- University of Pittsburgh .Recruiting
- Medical Uni of South CarolinaRecruiting
- Prisma Health Upstate .
- University of Texas Medical School CFTY720D2399E1Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crizanlizumab
Arm Description
5 mg/kg by intravenous infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51
Outcomes
Primary Outcome Measures
Percent change in priapic events from baseline to 26 weeks
Priapism is defined as an unwanted or painful penile erection lasting at least 60 minutes. The end of the priapic event will be the duration when the unwanted erection has resolved. This event will be self-reported via an electronic reporting system, and this data should be collected throughout the study period.
Secondary Outcome Measures
Rate of priapic events
The rate of priapic events is defined as the total number of priapic events for a subject occurring from the date of initial infusion to the last contact date of the Treatment Phase
Percent change in acute priapic events from baseline to 26 weeks
An acute priapic event is defined as an unwanted, painful erection that lasts more than 4 hours and need a visit to emergency room.
Rate of uncomplicated vaso-occlusive crises
The number of uncomplicated VOC events (defined as an acute event of pain with no known cause for pain other than a vaso occlusive event; and requiring treatment with a parenteral or oral opioids or other parenteral analgesic; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism). Events include both healthcare and self-reported events.
Rate of complicated vaso-occlusive crises
The number of complicated VOCs (defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism) recorded by healthcare visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03938454
Brief Title
A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
Acronym
SPARTAN
Official Title
A Prospective Phase II, Open-Label, Single-arm, Multicenter, Study to Assess Efficacy and Safety of SEG101 (Crizanlizumab), in Sickle Cell Disease Patients With Priapism (SPARTAN)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
November 3, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Priapism
Keywords
Priapism, sickle cell disease, SCD, crizanlizumab, P-selectin, SEG101, monoclonal antibody, prolonged erection, painful erection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Crizanlizumab
Arm Type
Experimental
Arm Description
5 mg/kg by intravenous infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51
Intervention Type
Drug
Intervention Name(s)
crizanlizumab
Other Intervention Name(s)
SEG101
Intervention Description
Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab
Primary Outcome Measure Information:
Title
Percent change in priapic events from baseline to 26 weeks
Description
Priapism is defined as an unwanted or painful penile erection lasting at least 60 minutes. The end of the priapic event will be the duration when the unwanted erection has resolved. This event will be self-reported via an electronic reporting system, and this data should be collected throughout the study period.
Time Frame
Baseline up to 26 weeks
Secondary Outcome Measure Information:
Title
Rate of priapic events
Description
The rate of priapic events is defined as the total number of priapic events for a subject occurring from the date of initial infusion to the last contact date of the Treatment Phase
Time Frame
Baseline up to 26 and 52 weeks
Title
Percent change in acute priapic events from baseline to 26 weeks
Description
An acute priapic event is defined as an unwanted, painful erection that lasts more than 4 hours and need a visit to emergency room.
Time Frame
Baseline up to 26 and 52 weeks
Title
Rate of uncomplicated vaso-occlusive crises
Description
The number of uncomplicated VOC events (defined as an acute event of pain with no known cause for pain other than a vaso occlusive event; and requiring treatment with a parenteral or oral opioids or other parenteral analgesic; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism). Events include both healthcare and self-reported events.
Time Frame
Baseline up to 26 and 52 weeks
Title
Rate of complicated vaso-occlusive crises
Description
The number of complicated VOCs (defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism) recorded by healthcare visit.
Time Frame
Baseline up to 26 and 52 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Male patients aged 16 years and above
Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography. All SCD genotypes are eligible (HbSS, HbSβ0, HbSC, HbSβ+, and others)
Experienced 4 or more priapic events (unwanted erection lasting at least 60 minutes) over the 14 weeks preceding study participation
Experienced at least 3 priapic events (unwanted erection lasting at least 60 minutes) during the 12 week screening period with at least 1 event occurring within 4 weeks prior to the first treatment.
If receiving hydroxyurea/hydroxycarbamide or L-glutamine or erythropoietin stimulating agent or voxelotor, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
If receiving prophylactic treatment for priapism, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
Exclusion criteria:
Had penile prosthetic implants or shunts or any other surgical procedure on the penis performed within 12 months prior to consenting are not allowed
Took drugs/medications that may induce priapism over the 14 weeks preceding study entry
Received leuprolide acetate (Lupron) within 3 months before pre-screening.
Had an erection lasting more than 12 hours over the 14 week preceding study entry
Had an erection lasting more than 12 hours during the 12 weeks of the screening period
Other protocol-defined inclusion/exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
usoncology.medinfo@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Facility Information:
Facility Name
University of Alabama .
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Completed
Facility Name
University of Connecticut Health Center .
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Completed
Facility Name
Childrens National Hospital SC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Foundation for Sickle Cell Disease Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Completed
Facility Name
Emory University School of Medicine/Winship Cancer Institute .
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Completed
Facility Name
Childrens Healthcare of Atlanta .
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Clark Brown
Facility Name
Georgia Health Sciences University .
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Kutlar
Facility Name
LSU Medical Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Individual Site Status
Completed
Facility Name
Childrens Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Withdrawn
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
718-918-5642
First Name & Middle Initial & Last Name & Degree
Kenneth Rivlin
Facility Name
Montefiore Medical Center .
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Completed
Facility Name
NYC H Hospital Queens Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Ferman
Facility Name
Levine Cancer Insitute Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
980-442-2000
First Name & Middle Initial & Last Name & Degree
Ifeyinwa Osunkwo
Facility Name
Duke University Medical Center .
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Brody School of Medicine .
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Completed
Facility Name
University of Pittsburgh .
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura DeCastro
Facility Name
Medical Uni of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
843-792-1815
First Name & Middle Initial & Last Name & Degree
Shayla Bergmann
Facility Name
Prisma Health Upstate .
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Completed
Facility Name
University of Texas Medical School CFTY720D2399E1
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
713-500-7107
First Name & Middle Initial & Last Name & Degree
Modupe Idowu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
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