Phase 2
N=36
A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
Priapism
Bottom Line
View on ClinicalTrials.gov: NCT03938454 ↗Enrolled (actual)
36
Serious AEs
19.4%
Results posted
Mar 2025
Primary outcome: Primary: Percent Change in Priapic Events From Baseline to 26 Weeks — -61.3 Percent change from baseline — p=0.0676
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Crizanlizumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Male
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Priapic Events From Baseline to 26 Weeks |
-61.3 | 0.0676 |
| SECONDARY Annualized Rate of Priapic Events |
31.1; 25.6 | — |
| SECONDARY Number of Acute Priapic Events From Baseline to 26 and 52 Weeks |
7.0; 1.5; 1.0 | — |
| SECONDARY Annualized Rate of Uncomplicated Vaso-occlusive Crises (VOCs) |
4.1; 2.5 | — |
| SECONDARY Annualized Rate of Complicated VOCs |
1.9; 1.4 | — |
Summary
The goal of the study was to evaluate the efficacy and safety of crizanlizumab in sickle cell disease (SCD) patients with priapism.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03938454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.