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

Completed · Phase 2

Conditions studied: Priapism

In brief

The goal of the study was to evaluate the efficacy and safety of crizanlizumab in sickle cell disease (SCD) patients with priapism.

Key facts

Study ID

NCT03938454

Run by

Novartis Pharmaceuticals

People needed

36

Starts

2019-10-16

Expected to finish

2023-11-29

Last updated by the study team

2026-01-13

Who can join

Age: 12 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients aged 12 years and above
• Confirmed diagnosis of SCD by hemoglobin electrophoresis or high-performance liquid chromatography. All SCD genotypes were 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 or voxelotor, must have been receiving the drug for at least 14 weeks prior to screening and planned 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 planned to continue taking the drug at the same dose and schedule during the trial
• Written informed consent (or assent/parental consent for minor participants) prior to any screening procedures

You may not qualify if…

• Had penile prosthetic implants or shunts or any other surgical procedure on the penis performed within 12 months prior to consenting was not allowed
• Took drugs/medications that may induce priapism over the 14 weeks preceding study entry
• Received leuprolide acetate (Lupron) or any other gonadotropin releasing hormone receptor agonist agent within 3 months before pre-screening
• Had an erection lasting more than 12 hours over the 14 weeks preceding study entry
• Had an erection lasting more than 12 hours during the 12 weeks of the Screening period

Where it is running

• University Of Alabama — Birmingham, Alabama, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Childrens National Hospital — Washington D.C., District of Columbia, United States
• Foundation for Sickle Cell Disease Research — Hollywood, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• LSU Medical Center — Shreveport, Louisiana, United States
• Childrens Hosp Boston Dept of Hematology — Boston, Massachusetts, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Brody School of Medicine — Greenville, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Prisma Health Upstate — Greenville, South Carolina, United States
• University of Texas Medical School — Houston, Texas, United States

Full record on ClinicalTrials.gov

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