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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03938454

Collaborator

(none)

Enrollment

Locations

Arm

48.6

Anticipated Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

Anticipated 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 :

Oct 16, 2019

Anticipated Primary Completion Date :

Jan 26, 2023

Anticipated Study Completion Date :

Nov 3, 2023

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 Names: SEG101

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 Names:

SEG101

Outcome Measures

Primary Outcome Measures

Percent change in priapic events from baseline to 26 weeks [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

Rate of priapic events [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 [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 [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 [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

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	University of Connecticut Health Center	Farmington	Connecticut	United States	06030
3	Children s National Hospital SC	Washington	District of Columbia	United States	20010
4	Foundation for Sickle Cell Disease Research	Hollywood	Florida	United States	33021
5	Emory University School of Medicine/Winship Cancer Institute	Atlanta	Georgia	United States	30303
6	Childrens Healthcare of Atlanta	Atlanta	Georgia	United States	30342
7	Georgia Health Sciences University	Augusta	Georgia	United States	30912
8	LSU Medical Center	Shreveport	Louisiana	United States	71130
9	Childrens Hospital Boston	Boston	Massachusetts	United States	02115
10	Jacobi Medical Center	Bronx	New York	United States	10461
11	Montefiore Medical Center	Bronx	New York	United States	10461
12	NYC H Hospital Queens Cancer Center	New York	New York	United States	11432
13	Levine Cancer Insitute Carolinas Healthcare System	Charlotte	North Carolina	United States	28204
14	Duke University Medical Center	Durham	North Carolina	United States	27710
15	Brody School of Medicine	Greenville	North Carolina	United States	27834
16	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213-2548
17	Medical University of South Carolina	Charleston	South Carolina	United States	29425
18	Prisma Health Upstate	Greenville	South Carolina	United States	29615
19	University of Texas Medical School CFTY720D2399E1	Houston	Texas	United States	77030