Recruiting

Crizanlizumab

Sponsor:

Novartis Pharmaceuticals

Code:

NCT04657822

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Crizanlizumab

Study Details

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.

Conditions

Sickle Cell Disease

Study ID

NCT04657822

Start date

Jun 10, 2021

Status verified date

Jun, 2026

Completion date

Jun 10, 2031

Anticipated

Primary completion date

Jun 10, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. 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
3. 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:

1. Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion
2. 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
3. Concurrent participation in any other investigational clinical trial other than the parent 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 effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab
6. SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Crizanlizumab

All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.

Interventions

Crizanlizumab

Concentrate for solution for infusion for Intravenous use

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 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111

Locations

University Of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Chibuzo Churchill Ilonze

Augusta University Georgia

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Abdullah Kutlar

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • SCD
  • Vaso-occlusive Crisis
  • crizanlizumab
  • SEG101
  • Sickle cell disease
  • Sickle cell disorder
  • VOC
  • P-selectin
  • Sickle cell anemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-06-08.