Continuation of crizanlizumab treatment for sickle cell disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, multinational rollover study allows patients with sickle cell disease who have previously participated in a Novartis-sponsored crizanlizumab study to continue receiving the treatment. Eligible participants will transfer directly from their parent study without a screening period, starting crizanlizumab treatment as per the established schedule. The study aims to monitor the safety and efficacy of crizanlizumab over an extended period, with follow-up visits scheduled after treatment. The study is expected to last up to 10 years or until the treatment becomes commercially available.

Why it matters

Who can join: the full rules

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

Where it's running

• University Of Alabama
  Birmingham, Alabama, United States Recruiting
• Augusta University Georgia
  Augusta, Georgia, United States Recruiting
• Novartis Investigative Site
  Barranquilla, Atlántico, Colombia Recruiting
• Novartis Investigative Site
  Valledupar, Cesar Department, Colombia Recruiting
• Novartis Investigative Site
  Beirut, Lebanon Recruiting
• Novartis Investigative Site
  Tripoli, Lebanon Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating Crizanlizumab for Sickle Cell Disease in Adolescents and Adults

  This study is testing if a new medication called crizanlizumab can help reduce painful episodes in adolescents and adults with sickle cell disease.

  Recruiting at 35 sites Phase 3 Novartis · Birmingham, Alabama and 35 other locations · NCT06439082

• Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients

  This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07776444

• Adapting and testing PEN-Plus in Zambian primary care

  Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.

  Recruiting Centre for Infectious Disease Research in Zambia · Lusaka, Lusaka Province · NCT07753681

• Newborn Sickle Cell Screening in Mozambique

  We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.

  Recruiting St. Jude Children's Research Hospital · Nhamatanda, Sofala · NCT07719972

• Optimizing Hydroxyurea in Children with Sickle Cell in Africa

  This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.

  Recruiting Phase 1/2 Children's Hospital Medical Center, Cincinnati · Kampala · NCT07708714

• Hematopoietic stem cell editing to treat sickle cell disease

  This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.

  Recruiting Phase 1 Boston Children's Hospital · Boston, Massachusetts · NCT07708350

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.