Health Condition 1: D570- Hb-SS disease with crisis
Conditions
Interventions
Intervention1: Crizanlizumab (SEG101): at 5.0 mg/kg dose At day 1,day 15 and than every 4 weeks till week 51 with or without hydroxyurea
Control Intervention1: NA: NA
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Signed informed consent must be obtained prior to participation in the study 2. Male or female participants aged 16 years and older on the day of signing informed consent 3. Confirmed diagnosis of sickle cell disease by hemoglobin electrophoresis or high performance liquid chromatography 4. Concomitant sickle cell therapy with hydroxyurea/hydroxycarbamide is permitted 5. History of vaso-occlusive crisis leading to healthcare visit prior to screening visit as determined by medical history and investigator assessment 6. Participants must meet the following central laboratory values at the screening visit: Absolute Neutrophil Count =1.0 x 109/L ? Platelet count =75 x 109/L ? Hemoglobin: for adults (Hb) =4.0 g/dL and for adolescents (Hb) =5.5 g/dL ? Glomerular filtration rate = 45 mL/min/1.73 m2 using CKD-EPI formula ? Direct (conjugated) bilirubin ? Alanine Aminotransferase (ALT) ? ECOG Performance Status =2 for adults and Karnofsky Performance Scale = 50% for adolescents
Exclusion criteria
Exclusion criteria: 1. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. 2. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction ? participant has received crizanlizumab and/or other P-selectin inhibitor prior to the study or plans to receive it during the duration of the study. 3. Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the Investigator, could cause unacceptable safety risks or compromise participation in the study 4. Participant has documented immunogenicity to a prior biological drug 5. Participants who are on active treatment with Voxelotor, other investigational drug or other monoclonal antibody, or intend to initiate the same during the course of the trial 6. Pregnant females or females who have given birth within the past 90 days or who are breastfeeding, and women of child-bearing potential unless they are using effective methods of contraception during dosing and for 15 weeks after stopping treatment 7. Clinically significant bleeding disorder ? Positive test for hepatitis C ribonucleic acid (HCV RNA). ? Malignant disease ? participant has significant active infection (i.e. HIV, hepatitis B , COVID-19 infections) or immune deficiency (including chronic use of immunosuppressive drugs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the serious adverse events (SAEs) of crizanlizumab in Indian patients with SCDTimepoint: Frequency, severity and causality of SAEs during the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the overall safety and tolerability of crizanlizumab in Indian patients with SCDTimepoint: Safety assessments will consist of monitoring and recording all AEs, based on CTCAE v5.0. 1. Pre-treatment period: from day of participant?s informed consent to the day before first dose of study medication 2. On-treatment period: from day of first dose of study medication to 105 days after last dose of study medication 3. Post-treatment period: starting at day 105 plus 1 after last dose of study medication | — |
Countries
India
Contacts
Public ContactMurugananthan K
Novartis Healthcare PVT LTD
Outcome results
None listed