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

Last updated: October 24, 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:
June 10, 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

    Site Not Available

  • Novartis Investigative Site

    Brussels 2800866, 1000
    Belgium

    Completed

  • Novartis Investigative Site

    Laeken, 1020
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Laken 2793656, 1020
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liege, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Salvador, BA 41253-190
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Salvador 3450554, Estado de Bahia 3471168 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

    Ribeirão Preto 3451328, São Paulo 3448433 14051-140
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo 3448439, São Paulo 3448433 01232-010
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Cali, Valle Del Cauca 760012
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Cali 3687925, Valle del Cauca Department 3666313 760012
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Monteria, 230004
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Montería 3674453, 230004
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Creteil, 94010
    France

    Site Not Available

  • Novartis Investigative Site

    Créteil 3022530, 94010
    France

    Completed

  • Novartis Investigative Site

    Paris, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Paris 2988507, 75015
    France

    Completed

  • Novartis Investigative Site

    Paris 15, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Paris cedex 15, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heidelberg 2907911, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Padova, PD 35128
    Italy

    Site Not Available

  • Novartis Investigative Site

    Padua 3171728, PD 35128
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano, TO 10043
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano 3171986, TO 10043
    Italy

    Completed

  • Novartis Investigative Site

    Beirut, 1107 2020
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Beirut 276781, 113-0236
    Lebanon

    Active - Recruiting

  • Novartis Investigative Site

    Tripoli, 1434
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Tripoli 266826, 1434
    Lebanon

    Active - Recruiting

  • Novartis Investigative Site

    Khoudh, 123
    Oman

    Active - Recruiting

  • Novartis Investigative Site

    Muscat, 123
    Oman

    Site Not Available

  • Novartis Investigative Site

    Barcelona 3128760, Catalonia 3336901 08035
    Spain

    Completed

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid 3117735, 28009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Adana, 01250
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Antakya / Hatay, 31100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Antakya Hatay, 31100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Hatay 9922457, Antakya 31101
    Turkey (Türkiye)

    Site Not Available

  • Novartis Investigative Site

    Adana 325363, Yuregir 01250
    Turkey (Türkiye)

    Site Not Available

  • Novartis Investigative Site

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University Of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University Of Alabama

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Novartis Investigative Site

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Augusta University Georgia

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Augusta University Georgia Patient Treatment

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Augusta University Georgia

    Augusta 4180531, Georgia 4197000 30912
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • 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

  • East Carolina University

    Greenville 4469160, North Carolina 4482348 27858
    United States

    Completed

  • Childrens Hospital Of Philadelphia

    Philadelphia, Pennsylvania 19104-4399
    United States

    Site Not Available

  • 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

  • Childrens Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104-4399
    United States

    Active - Recruiting

  • Cook Childrens Medical Center

    Fort Worth, Texas 76104
    United States

    Completed

  • Novartis Investigative Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Cook Childrens Medical Center

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Completed

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