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
2 other identifiers
interventional
130
11 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2021
Longer than P75 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 10, 2031
October 27, 2025
October 1, 2025
10 years
December 1, 2020
October 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study
Protocol to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study, benefited from the treatment and do not have access to reimbursed, commercially available crizanlizumab.
Not Applicable - Study Completion
Secondary Outcomes (1)
Number of participants with treatment emergent adverse events
from day of first dose of study medication to 105 days after last dose of study medication
Study Arms (1)
Crizanlizumab
EXPERIMENTALAll participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.
Interventions
Concentrate for solution for infusion for Intravenous use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
University Of Alabama
Birmingham, Alabama, 35233, United States
Childrens National Hospital
Washington D.C., District of Columbia, 20010, United States
Augusta University Georgia
Augusta, Georgia, 30912, United States
East Carolina University
Greenville, North Carolina, 27834, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399, United States
Cook Childrens Medical Center
Fort Worth, Texas, 76104, United States
Novartis Investigative Site
Brussels, 1000, Belgium
Novartis Investigative Site
Laken, 1020, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Salvador, Estado de Bahia, 41253-190, Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14051-140, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 01232-010, Brazil
Novartis Investigative Site
Cali, Valle del Cauca Department, 760012, Colombia
Novartis Investigative Site
Montería, 230004, Colombia
Novartis Investigative Site
Créteil, 94010, France
Novartis Investigative Site
Paris, 75015, France
Novartis Investigative Site
Paris, 75015, France
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Padua, PD, 35128, Italy
Novartis Investigative Site
Orbassano, TO, 10043, Italy
Novartis Investigative Site
Beirut, 113-0236, Lebanon
Novartis Investigative Site
Tripoli, 1434, Lebanon
Novartis Investigative Site
Khoudh, 123, Oman
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Madrid, 28009, Spain
Novartis Investigative Site
Hatay, Antakya, 31101, Turkey (Türkiye)
Novartis Investigative Site
Adana, Saricam, 01330, Turkey (Türkiye)
Novartis Investigative Site
Adana, Yuregir, 01250, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 8, 2020
Study Start
June 10, 2021
Primary Completion (Estimated)
June 10, 2031
Study Completion (Estimated)
June 10, 2031
Last Updated
October 27, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.