Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Sickle Cell Disease (SCD)
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
Brief Summary
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 s...
Detailed Description
Study CSEG101A2202 was designed as a Phase II, multicenter, open-label study. The first 45 patients (to identify 27 evaluable patients) were enrolled to the treatment group crizanlizumab 5.0 mg/kg to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03264989
Start Date
December 19 2017
End Date
June 26 2023
Last Update
October 9 2024
Active Locations (12)
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1
Novartis Investigative Site
Orange, Florida, United States, 32763
2
Novartis Investigative Site
Tampa, Florida, United States, 33606
3
Childrens Healthcare of Atlanta .
Atlanta, Georgia, United States, 30342
4
Augusta University Georgia Patient Treatment
Augusta, Georgia, United States, 30912