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RecruitingPhase 4

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

Novartis Pharmaceuticals · NCT04657822

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6 mo–100 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 4
Target enrollment
130
US sites recruiting
2
Study start
June 10, 2021
Record last updated
June 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Crizanlizumab

Conditions: Sickle Cell Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University Of Alabama

    Birmingham, AL 35233

    Site contact: Jeanine Dumas · +1 205 638 2792 · jdumas@uabmc.edu

  • Augusta University Georgia

    Augusta, GA 30912

    Site contact: Latanya Bowman · 706-721-2171 · lbowman@augusta.edu

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
Rollover Study for Patients With Sickle Cell Disease Who Have… (NCT04657822) | Bored Studies