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

ClinicalTrials.gov Identifier: NCT04657822

Novartis Reference Number: CSEG101A2401B

Last Update: Feb 23, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Sickle Cell Disease

Phase

Phase 4

Overall status

Recruiting

Start date

Jun 10, 2021

Completion date

Oct 27, 2031

Gender

All

Age(s)

6 Years and older (Child, Adult, Older Adult)

Interventions

Drug

Crizanlizumab

Concentrate for solution for infusion for Intravenous use

Eligibility Criteria

Inclusion Criteria:

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
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
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:

Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion
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
Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial
Pregnant or nursing women
Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab
SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab