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)

About the study

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

Study point of contact

Novartis Pharmaceuticals
Novartis Pharmaceuticals
1-888-669-6682
usoncology.medinfo@novartis.com

Locations

19 United States sites

Age

> 16 Years

Genotypes

HbSS, HbSC

Phase

Phase 2

Study type

Interventional

Gender

Male

Interventions

Drug

participation requirements

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

participation restrictions

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

Locations

  • Birmingham, Alabama, United States, University of Alabama, 35294 [Recruiting]
  • Farmington, Connecticut, United States, University of Connecticut Health Center, 06030 [Recruiting]
  • Washington, District of Columbia, United States, Children s National Hospital SC, 20010 [Recruiting]
  • Hollywood, Florida, United States, Foundation for Sickle Cell Disease Research, 33021 [Recruiting]
  • Atlanta, Georgia, United States, Emory University School of Medicine/Winship Cancer Institute, 30303 [Recruiting]
  • Atlanta, Georgia, United States, Childrens Healthcare of Atlanta, 30342 [Recruiting]
  • Augusta, Georgia, United States, Georgia Health Sciences University, 30912 [Recruiting]
  • Shreveport, Louisiana, United States, LSU Medical Center, 71130 [Recruiting]
  • Boston, Massachusetts, United States, Childrens Hospital Boston, 02115 [Recruiting]
  • Bronx, New York, United States, Jacobi Medical Center, 10461 [Recruiting]
  • Bronx, New York, United States, Montefiore Medical Center, 10461 [Recruiting]
  • New York, New York, United States, NYC H Hospital Queens Cancer Center, 11432 [Recruiting]
  • Charlotte, North Carolina, United States, Levine Cancer Insitute Carolinas Healthcare System, 28204 [Recruiting]
  • Durham, North Carolina, United States, Duke University Medical Center, 27710 [Recruiting]
  • Greenville, North Carolina, United States, Brody School of Medicine, 27834 [Recruiting]
  • Pittsburgh, Pennsylvania, United States, University of Pittsburgh, 15213-2548 [Recruiting]
  • Charleston, South Carolina, United States, Medical University of South Carolina, 29425 [Recruiting]
  • Greenville, South Carolina, United States, Prisma Health Upstate, 29615 [Completed]
  • Houston, Texas, United States, University of Texas Medical School CFTY720D2399E1, 77030 [Recruiting]
Last updated 2021-11-16