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出境医 / 临床实验 / A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism (SPARTAN)

A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism (SPARTAN)

Study Description
Brief Summary:
The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.

Condition or disease Intervention/treatment Phase
Priapism Drug: crizanlizumab Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : March 4, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Crizanlizumab
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
 Drug: crizanlizumab
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
Other Name: SEG101
Outcome Measures
Primary Outcome Measures :
  1. Percent change in priapic events from baseline to 26 weeks [ Time Frame: Baseline up 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 :
  1. Rate of priapic events [ Time Frame: Baseline up to 26 and 52 weeks ]
    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

  2. Percent change in acute priapic events from baseline to 26 weeks [ Time Frame: Baseline up to 26 and 52 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.

  3. Rate of uncomplicated vaso-occlusive crises [ Time Frame: Baseline up to 26 and 52 weeks ]
    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.

  4. Rate of complicated vaso-occlusive crises [ Time Frame: Baseline up to 26 and 52 weeks ]
    The number of complicated VOCs (defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism) recorded by healthcare visit.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 usoncology.medinfo@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Show Show 17 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE October 16, 2019
Estimated Primary Completion Date May 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019) 		Percent change in priapic events from baseline to 26 weeks [ Time Frame: Baseline up 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Rate of priapic events [ Time Frame: Baseline up to 26 and 52 weeks ]
    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 [ Time Frame: Baseline up to 26 and 52 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 [ Time Frame: Baseline up to 26 and 52 weeks ]
    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 [ Time Frame: Baseline up to 26 and 52 weeks ]
    The number of complicated VOCs (defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism) recorded by healthcare visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
Official Title  ICMJE 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)
Brief Summary The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Priapism
Intervention  ICMJE Drug: crizanlizumab
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
Other Name: SEG101
Study Arms  ICMJE Experimental: Crizanlizumab
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: Drug: crizanlizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019) 		56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 4, 2022
Estimated Primary Completion Date May 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 usoncology.medinfo@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938454
Other Study ID Numbers  ICMJE CSEG101AUS05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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