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

Phase 2

Completed

• Conditions: Priapism
• Interventions: Drug: crizanlizumab

• Registration Number: NCT03938454
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-10-16
• Primary Completion: 2023-03-28
• Disposition First Submitted: 2023-10-31
• Study Completion: 2023-11-29
• Disposition First Posted: 2024-01-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Crizanlizumab	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

Primary Outcome Measures

Name	Time	Method
Percent change in priapic events from baseline to 26 weeks	Baseline up to 26 weeks	Priapism is defined as an unwanted or painful penile erection lasting at least 60 minutes. The end of the priapic event will be the duration when the unwanted erection has resolved. This event will be self-reported via an electronic reporting system, and this data should be collected throughout the study period.

Secondary Outcome Measures

Name	Time	Method
Rate of complicated vaso-occlusive crises	Baseline up to 26 and 52 weeks	The number of complicated VOCs (defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism) recorded by healthcare visit.
Rate of priapic events	Baseline up to 26 and 52 weeks	The rate of priapic events is defined as the total number of priapic events for a subject occurring from the date of initial infusion to the last contact date of the Treatment Phase
Percent change in acute priapic events from baseline to 26 weeks	Baseline up to 26 and 52 weeks	An acute priapic event is defined as an unwanted, painful erection that lasts more than 4 hours and need a visit to emergency room.
Rate of uncomplicated vaso-occlusive crises	Baseline up to 26 and 52 weeks	The number of uncomplicated VOC events (defined as an acute event of pain with no known cause for pain other than a vaso occlusive event; and requiring treatment with a parenteral or oral opioids or other parenteral analgesic; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism). Events include both healthcare and self-reported events.

Trial Locations

Locations (13)

Childrens Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh .; 🇺🇸 Pittsburgh, Pennsylvania, 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

Prisma Health Upstate .; 🇺🇸 Greenville, South Carolina, United States

University of Connecticut Health Center .; 🇺🇸 Farmington, Connecticut, United States

Childrens National Hospital SC; 🇺🇸 Washington, District of Columbia, United States

University Of Alabama .; 🇺🇸 Birmingham, Alabama, United States

Duke University Medical Center .; 🇺🇸 Durham, North Carolina, United States

Brody School of Medicine .; 🇺🇸 Greenville, North Carolina, United States

University of Texas Medical School CFTY720D2399E1; 🇺🇸 Houston, Texas, United States

Montefiore Medical Center .; 🇺🇸 Bronx, New York, United States