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Continuation of crizanlizumab treatment for sickle cell disease patients

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

Phase 4 Interventional Novartis · NCT04657822

This study is for people with sickle cell disease who have already tried crizanlizumab and want to keep using it to see how well it works and if it's safe over a longer time.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment130 (estimated)
Ages6 Months to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionscrizanlizumab
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT04657822 on ClinicalTrials.gov

What this trial studies

This multi-center, multinational rollover study allows patients with sickle cell disease who have previously participated in a Novartis-sponsored crizanlizumab study to continue receiving the treatment. Eligible participants will transfer directly from their parent study without a screening period, starting crizanlizumab treatment as per the established schedule. The study aims to monitor the safety and efficacy of crizanlizumab over an extended period, with follow-up visits scheduled after treatment. The study is expected to last up to 10 years or until the treatment becomes commercially available.

Who should consider this trial

Good fit: Ideal candidates are patients with sickle cell disease who are currently enrolled in a Novartis-sponsored study and are benefiting from crizanlizumab treatment.

Not a fit: Patients who have permanently discontinued crizanlizumab treatment in the parent study will not benefit from this rollover study.

Why it matters

Potential benefit: If successful, this study could provide ongoing access to crizanlizumab for patients benefiting from its treatment for sickle cell disease.

How similar studies have performed: Other studies involving crizanlizumab have shown promising results, indicating a potential for continued success with this rollover approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sickle Cell DiseaseSCDVaso-occlusive CrisiscrizanlizumabSEG101Sickle cell diseaseSickle cell disorderVOC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.