Children's National

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

Purpose

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

Condition

Priapism

Eligibility

Eligible Ages: Over 16 Years
Eligible Genders: Male
Accepts Healthy Volunteers: No

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 or voxelotor, 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 performed within 12 months prior to consenting are not allowed - 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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

More Details

NCT ID: NCT03938454
Status: Completed
Sponsor: Novartis Pharmaceuticals

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.