Sickle Cell DiseasePhase 4NCT04657822
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
A Phase 4 study testing Crizanlizumab in people with Sickle Cell Disease, run by Novartis Pharmaceuticals at 31 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 100 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Crizanlizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 31 sitesin 11 countries
- Study dates
- 10 Jun 2021to 10 Jun 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
31 sites in 11 countries
United States7 sites, 2 recruiting
- Recruiting
Augusta University Georgia
Augusta, Georgia, 30912
Latanya Bowman, 706-721-2171, lbowman@augusta.edu
Abdullah Kutlar
- Recruiting
University Of Alabama
Birmingham, Alabama, 35233
Jeanine Dumas, +1 205 638 2792, jdumas@uabmc.edu
Chibuzo Churchill Ilonze
- Completed
Cook Childrens Medical Center
Fort Worth, Texas, 76104
- Completed
East Carolina University
Greenville, North Carolina, 27834
- Completed
East Carolina University
Greenville, North Carolina, 27858
- Active, not recruiting
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
- Active, not recruiting
Childrens National Hospital
Washington D.C., District of Columbia, 20010
Colombia4 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, 080020
- Active, not recruiting
Novartis Investigative Site
Cali, Valle del Cauca Department, 760032
- Active, not recruiting
Novartis Investigative Site
Montería, 230004
- Recruiting
Novartis Investigative Site
Valledupar, Cesar Department, 200001
Belgium3 sites
- Completed
Novartis Investigative Site
Brussels, 1000
- Active, not recruiting
Novartis Investigative Site
Laken, 1020
- Active, not recruiting
Novartis Investigative Site
Liège, 4000
Brazil3 sites
- Active, not recruiting
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14051-140
- Active, not recruiting
Novartis Investigative Site
Salvador, Estado de Bahia, 41253-190
- Active, not recruiting
Novartis Investigative Site
São Paulo, São Paulo, 01232-010
France3 sites
- Completed
Novartis Investigative Site
Créteil, 94010
- Active, not recruiting
Novartis Investigative Site
Paris, 75015
- Completed
Novartis Investigative Site
Paris, 75015
Turkey (Türkiye)3 sites
- Active, not recruiting
Novartis Investigative Site
Adana, Saricam, 01330
- Active, not recruiting
Novartis Investigative Site
Adana, Yuregir, 01250
- Withdrawn
Novartis Investigative Site
Hatay, Antakya, 31101
Italy2 sites
- Completed
Novartis Investigative Site
Orbassano, TO, 10043
- Active, not recruiting
Novartis Investigative Site
Padova, PD, 35128
Lebanon2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Beirut, 113-0236
- Recruiting
Novartis Investigative Site
Tripoli, 1434
Spain2 sites
- Completed
Novartis Investigative Site
Barcelona, 08035
- Active, not recruiting
Novartis Investigative Site
Madrid, 28009
Germany1 site
- Active, not recruiting
Novartis Investigative Site
Heidelberg, 69120
About this study
Official title: An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
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.
Read the detailed 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
- Conditions
- Sickle Cell Disease
- Being tested
- Crizanlizumab
- Keywords
- SCD, Vaso-occlusive Crisis, crizanlizumab, SEG101, Sickle cell disease, Sickle cell disorder, VOC, P-selectin, Sickle cell anemia
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizanlizumabDrug
Also called SEG101
Concentrate for solution for infusion for Intravenous use
| Study group | Role | What they receive |
|---|---|---|
| Crizanlizumab | Experimental | All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study. Receives: Drug: Crizanlizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Not Applicable - Study Completion
Secondary outcomes (1)
Number of participants with treatment emergent adverse events
The number of participants with Frequency, severity and causality of treatment emergent adverse events will be collected.
Measured: from day of first dose of study medication to 105 days after last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start10 Jun 2021
- Primary completion10 Jun 2031 (estimated)
- Study completion10 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657822
- Sponsor's protocol ID
- CSEG101A2401B
- Other IDs
- 2020-004225-22
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
- ClinicalTrials.gov ID
- NCT04657822
- Acronym / sponsor ID
- CSEG101A2401B
- Conditions
- Sickle Cell Disease
- Keywords
- SCD, Vaso-occlusive Crisis, crizanlizumab, SEG101, Sickle cell disease, Sickle cell disorder, VOC, P-selectin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Jun 2031 (estimated)
- Study completion
- 10 Jun 2031 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crizanlizumab | Experimental | Drug: CrizanlizumabAll participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study. |
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrizanlizumabAlso: SEG101Concentrate for solution for infusion for Intravenous use | Drug | Crizanlizumab |
Primary outcome
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
Time frame: Not Applicable - Study Completion
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.
1 secondary outcome
Number of participants with treatment emergent adverse events
Time frame: from day of first dose of study medication to 105 days after last dose of study medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
31 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crizanlizumab in people with Sickle Cell Disease, run by Novartis Pharmaceuticals at 31 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Colombia, Belgium, Brazil, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Not Applicable - Study Completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.