NCT04657822

Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Months – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

Detailed description

There will be no screening period for this study as patients will transfer directly from parent studies. After providing informed consent, all eligible participants should start Crizanlizumab treatment at the earliest convenience following the treatment schedule of 28 days of the last dose in the parent study. Crizanlizumab will be administered at the same dose/schedule as in the parent study. Study participants will have a safety follow up visit conducted 105 days after last administration of study treatment. The safety follow up at 105 days is not applicable for those participants who continue to receive Crizanlizumab after end of treatment visit either commercially or through PSDS. The study is expected to remain open for 10 years from the first Patient's first visit (FPFV) in this clinical study or until study treatment becomes commercially available and is reimbursed in the respective indication or until such time that all enrolled patients no longer need treatment with Crizanlizumab, or a PSDS treatment plan is allowed and approved as per local laws and regulations, whichever comes first

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Crizanlizumab	Concentrate for solution for infusion for Intravenous use

Timeline

• Start date: 2021-06-10
• Primary completion: 2031-06-10
• Completion: 2031-06-10
• First posted: 2020-12-08
• Last updated: 2026-04-07

Locations

30 sites across 11 countries: United States, Belgium, Brazil, Colombia, France, Germany, Italy, Lebanon, Oman, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study