All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.
Oct 22, 2020
Oct 16, 2019
Mar 04, 2022
16 Years and older (Child, Adult, Older Adult)
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
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
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
University of Alabama
University of Connecticut Health Center
Children s National Hospital SC
District of Columbia
Emory University School of Medicine/Winship Cancer Institute
Childrens Healthcare of Atlanta
Georgia Health Sciences University
LSU Medical Center
Jacobi Medical Center
Montefiore Medical Center
NYC H Hospital Queens Cancer Center
New York, 11432
Levine Cancer Insitute Carolinas Healthcare System