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

• Status: Recruiting
• Trial end date: 2023-04-21
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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