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

Study point of contact

Novartis Pharmaceuticals
Novartis Pharmaceuticals
+41613241111
[email protected]

Phase

Phase 4

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

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.

participation requirements

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

participation restrictions

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