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

Priapism Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938454
• Other study ID #: CSEG101AUS05
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2019
• Est. completion date: November 29, 2023

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 29, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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, HbSß0, HbSC, HbSß+, 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Priapism

Intervention

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

Locations

Country	Name	City	State
United States	Emory University School of Medicine .	Atlanta	Georgia
United States	University Of Alabama .	Birmingham	Alabama
United States	Childrens Hospital Boston	Boston	Massachusetts
United States	Montefiore Medical Center .	Bronx	New York
United States	Duke University Medical Center .	Durham	North Carolina
United States	University of Connecticut Health Center .	Farmington	Connecticut
United States	Brody School of Medicine .	Greenville	North Carolina
United States	Prisma Health Upstate .	Greenville	South Carolina
United States	Foundation for Sickle Cell Disease Research	Hollywood	Florida
United States	University of Texas Medical School CFTY720D2399E1	Houston	Texas
United States	University of Pittsburgh .	Pittsburgh	Pennsylvania
United States	LSU Medical Center	Shreveport	Louisiana
United States	Childrens National Hospital SC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 26 weeks
Secondary	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	Baseline up to 26 and 52 weeks
Secondary	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.	Baseline up to 26 and 52 weeks
Secondary	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.	Baseline up to 26 and 52 weeks
Secondary	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.	Baseline up to 26 and 52 weeks