drugset / Trial / NCT03938454

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

NCT03938454 ↗

Phase 2 Completed 36 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2019-10-16
Primary completion
2023-03-28
Completion
2023-11-29

Outcome

Missed primary endpoint

registry analysis (other test); Crizanlizumab 5 mg/kg; p = 0.0676; Hodges-Lehmann 45.98 (95% CI 23.50 to 65.36); Wilcoxon Sign Rank Test NCT03938454 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Crizanlizumab Monoclonal antibody 5 mg/kg Intravenous

Indications