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

Last updated: April 9, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Crizanlizumab

Clinical Study ID

NCT04657822
CSEG101A2401B
2020-004225-22
  • Ages 6-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent/assent, according to local guidelines, signed by the adultpatients. In the population under 18 years, it will be signed by the patient and/orby the parents or legal guardian prior to enrolling in the rollover study andreceiving study medication

  2. SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumaband has fulfilled all the requirements in the parent study. Patient is currentlybenefiting from the treatment with crizanlizumab as determined by the investigatorand has completed the treatment schedule as planned in the parent study

  3. Patient has demonstrated compliance to the planned visit schedule in the parentstudy, and in the opinion of the investigator has shown willingness and ability tocomply with future visit schedules

Exclusion

Exclusion Criteria:

  1. Patient had permanently discontinued from crizanlizumab study treatment in theparent study before the parent study completion

  2. Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AErequiring dose interruption. Patients meeting all other eligibility criteria may beenrolled once toxicities have resolved unless those toxicities were grade 4

  3. Concurrent participation in any other investigational clinical trial other than theparent 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 effectivecontraceptives during dosing and until 15 weeks after stopping treatment withcrizanlizumab

  6. SCD patients who do not meet parent study protocol criteria to continue withcrizanlizumab

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Crizanlizumab
Phase: 4
Study Start date:
June 10, 2021
Estimated Completion Date:
October 27, 2031

Study Description

There will be no screening period for this study as patients will transfer directly from parent studies. After providing informed consent, all eligible participants should start Crizanlizumab treatment at the earliest convenience following the treatment schedule of 28 days of the last dose in the parent study. Crizanlizumab will be administered at the same dose/schedule as in the parent study.

Study participants will have a safety follow up visit conducted 105 days after last administration of study treatment. The safety follow up at 105 days is not applicable for those participants who continue to receive Crizanlizumab after end of treatment visit either commercially or through PSDS.

The study is expected to remain open for 10 years from the first Patient's first visit (FPFV) in this clinical study or until study treatment becomes commercially available and is reimbursed in the respective indication or until such time that all enrolled patients no longer need treatment with Crizanlizumab, or a PSDS treatment plan is allowed and approved as per local laws and regulations, whichever comes first

Connect with a study center

  • Novartis Investigative Site

    Brussel, 1000
    Belgium

    Completed

  • Novartis Investigative Site

    Laeken, 1020
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Liege, 4000
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Salvador, BA 41253-190
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Ribeirao Preto, SP 14051-140
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 01232-010
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, SP 01232-010
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Cali, Valle Del Cauca 760012
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Monteria, 230004
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Creteil, 94010
    France

    Completed

  • Novartis Investigative Site

    Paris, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Paris 15, 75015
    France

    Completed

  • Novartis Investigative Site

    Paris cedex 15, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Padova, PD 35128
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Orbassano, TO 10043
    Italy

    Completed

  • Novartis Investigative Site

    Beirut, 1107 2020
    Lebanon

    Active - Recruiting

  • Novartis Investigative Site

    Tripoli, 1434
    Lebanon

    Active - Recruiting

  • Novartis Investigative Site

    Muscat, 123
    Oman

    Active - Recruiting

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28009
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Adana, 01250
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Antakya / Hatay, 31100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Antakya Hatay, 31100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University Of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Augusta University Georgia

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Augusta University Georgia Patient Treatment

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27858
    United States

    Completed

  • East Carolina University East Carolina University

    Greenville, North Carolina 27858
    United States

    Completed

  • East Carolina University SC

    Greenville, North Carolina 27834
    United States

    Completed

  • Novartis Investigative Site

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Childrens Hospital Of Philadelphia

    Philadelphia, Pennsylvania 19104-4399
    United States

    Active - Recruiting

  • Childrens Hospital Of Philadelphia Patient Treatment

    Philadelphia, Pennsylvania 19104-4399
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19104-4399
    United States

    Active - Recruiting

  • Cook Childrens Medical Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

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