Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)

Completed · Phase 2

Conditions studied: Sickle Cell Disease (SCD)

In brief

The purpose of the CSEG101A2202 study was to characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of SEG101/crizanlizumab and to evaluate the safety and efficacy of SEG101/crizanlizumab in sickle cell disease (SCD) patients.

Key facts

Study ID

NCT03264989

Run by

Novartis Pharmaceuticals

People needed

57

Starts

2017-12-19

Expected to finish

2023-06-26

Last updated by the study team

2024-10-09

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and non-pregnant female patients 16-70 years of age (inclusive)
• Confirmed diagnosis of sickle cell disease by hemoglobin electrophoresis or high-performance liquid chromatography (HPLC) [performed locally]. All sickle cell disease genotypes are eligible.
• Experienced at least 1 VOC within the preceding 12 months prior to Screening, as determined by medical history.
• If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the drug for at least 6 months prior to Screening
• Hemoglobin ≥4.0 g/dL. Absolute neutrophil count ≥1.0 x 109/L and platelet count ≥75 x 109/L
• Adequate renal and hepatic function as defined:
• GFR ≥45 mL/min/1.73 m2 calculated by CKD-EPI
• ALT ≤3 x ULN
• Direct (conjugated) bilirubin ≤2 x ULN
• ECOG performance status ≤2
• Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures

You may not qualify if…

• History of stem cell transplant.
• Acute VOC ending 7 days prior to first dosing
• Ongoing hospitalization prior to Screening
• Received blood products within 30 days to first dosing
• Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes)
• History of severe hypersensitivity reactions to other monoclonal antibodies
• Received a monoclonal antibody or immunoglobulin -based agent within 1 year of Screening, or has documented immunogenicity to a prior biologic.
• Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to Screening
• Significant active infection or immune deficiency (including chronic use of immunosuppressive drugs)
• Resting QTcF ≥470 msec at pretreatment (baseline) or other cardiac or cardiac repolarization abnormality

Where it is running

• Novartis Investigative Site — Orange, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Childrens Healthcare of Atlanta . — Atlanta, Georgia, United States
• Augusta University Georgia Patient Treatment — Augusta, Georgia, United States
• University of Maryland Medical Ctr — Baltimore, Maryland, United States
• Childrens Hospital at Montefiore — The Bronx, New York, United States
• Duke University Medical Center Patient Treatment — Durham, North Carolina, United States
• East Carolina University East Carolina University — Greenville, North Carolina, United States
• Childrens Hospital Of Philadelphia Patient Treatment — Philadelphia, Pennsylvania, United States
• Medical Uni of South Carolina Medical Univ of SC — Charleston, South Carolina, United States
• M Francisco Gonzalez MD PA . — Columbia, South Carolina, United States
• Carolina Blood and Cancer Care of South Carolina — Rock Hill, South Carolina, United States

Full record on ClinicalTrials.gov

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