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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04657822
• Other study ID #: CSEG101A2401B
• Secondary ID: 2020-004225-22
• Status: Recruiting
• Phase: Phase 4
• Start date: June 10, 2021
• Est. completion date: October 27, 2031

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 27, 2031
• Est. primary completion date: October 27, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

1. Written informed consent/assent, according to local guidelines, signed by the adult patients. In the population under 18 years, it will be signed by the patient and/or by the parents or legal guardian prior to enrolling in the rollover study and receiving study medication

2. SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements in the parent study. Patient is currently benefiting from the treatment with crizanlizumab as determined by the investigator and has completed the treatment schedule as planned in the parent study

3. Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and ability to comply with future visit schedules

Exclusion Criteria:

1. Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion

2. Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE requiring dose interruption. Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved unless those toxicities were grade 4

3. Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial

4. Pregnant or nursing women

5. Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab

6. SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Crizanlizumab
Concentrate for solution for infusion for Intravenous use

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Laeken
Belgium	Novartis Investigative Site	Liege
Brazil	Novartis Investigative Site	Ribeirao Preto	SP
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	São Paulo	SP
Colombia	Novartis Investigative Site	Cali	Valle Del Cauca
Colombia	Novartis Investigative Site	Monteria
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Paris 15
Germany	Novartis Investigative Site	Heidelberg
Italy	Novartis Investigative Site	Orbassano	TO
Italy	Novartis Investigative Site	Padova	PD
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Tripoli
Oman	Novartis Investigative Site	Muscat
Spain	Novartis Investigative Site	Madrid
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Antakya / Hatay
United States	Augusta University Georgia Patient Treatment	Augusta	Georgia
United States	University Of Alabama	Birmingham	Alabama
United States	Cook Childrens Medical Center	Fort Worth	Texas
United States	East Carolina University East Carolina University	Greenville	North Carolina
United States	East Carolina University SC	Greenville	North Carolina
United States	Childrens Hospital Of Philadelphia Patient Treatment	Philadelphia	Pennsylvania
United States	Childrens National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Colombia,  France,  Germany,  Italy,  Lebanon,  Oman,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study	Protocol to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study, benefited from the treatment and do not have access to reimbursed, commercially available crizanlizumab.	Not Applicable - Study Completion
Secondary	Number of participants with treatment emergent adverse events	The number of participants with Frequency, severity and causality of treatment emergent adverse events will be collected.	from day of first dose of study medication to 105 days after last dose of study medication