RightFit
RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Months to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study lets people with sickle cell disease keep getting crizanlizumab after finishing an earlier Novartis study. It is for people whose study doctor believes the treatment is helping them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a form agreeing to join before entering the study and getting study medicine. For patients under 18, the patient and/or a parent or legal guardian must sign, based on local rules.
  • Have sickle cell disease and be receiving crizanlizumab in a Novartis study. You must finish its planned treatment and meet all its requirements.
  • Your study doctor must believe crizanlizumab is helping you.
  • Have followed the earlier study’s visit schedule. Your study doctor must believe you can and will follow future visit schedules.

Who can't join

  • You permanently stopped crizanlizumab before the earlier study ended.
  • You still have severe treatment-related side effects (grade 3 or higher), or any side effect that requires pausing treatment. You may join after these clear up if you meet all other rules, unless they were grade 4, meaning life-threatening.
  • You are in, or plan to join, another study testing a treatment, other than the earlier crizanlizumab study.
  • You are pregnant or breastfeeding.
  • You can become pregnant and are unwilling to use highly effective birth control during treatment and for 15 weeks after stopping crizanlizumab.
  • You do not meet the earlier study’s rules for continuing crizanlizumab.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (7)

AL

DC

GA

NC

PA

TX