Adults 16 to 70, any sex, with Sickle Cell Disease (SCD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetic (PK): AUCd15 and AUCtau of Crizanlizumab at 5.0 mg/kg in Sickle Cell Disease (SCD) PatientsPrimary· 1st dose: Day 1: (pre-dose, 0.5, 1, 2, 4, 6 & 24 hours post dose, Days 4, 8 & 15; 5th dose: Day 1 (pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose), Days 4, 8, 15, 22 & 29
To characterize PK of crizanlizumab at 5.0 mg/kg in SCD patients. AUCd15: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) after single dose AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)
Starting dose (Week 1): AUCd15
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
13100
± 2810
Steady State (Week 15): AUCtau
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
20800
± 5030
PK: Cmax of Crizanlizumab at 5.0 mg/kg in Sickle Cell Disease (SCD) PatientsPrimary· After the starting dose (Week 1) and after multiple doses (steady state, Week 15)
To characterize PK of crizanlizumab at 5.0 mg/kg in SCD patients. Cmax: The maximum (peak) observed serum drug concentration after dose administration (mass x volume-1).
Starting dose (Week 1)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
102
± 29.8
Steady State (Week 15)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
123
± 36.4
Pre-dose Concentrations Prior to Each Study Drug DosePrimary· Pre-dose at Day 1 on Weeks 3, 7, 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, 51
To characterize PK of crizanlizumab at 5.0 mg/kg in SCD patients, by serum concentrations by treatment group.
Data was collected prior to each study drug dose; From Week 3 (loading dose), pre-dose (trough) concentrations were obtained every 4 weeks.
Week (W) 3 Day 1 (D)1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
18.0
± 6.42
W7 D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
10.8
± 5.21
W11 D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
9.04
± 5.04
W15 D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
10.0
± 5.39
W19 D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
9.37
± 4.95
W23 D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
9.91
± 5.09
W27 D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
9.65
± 4.03
W31 D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
9.75
± 4.66
Percentage of P-selectin Inhibition After the Starting Dose (PD-AUCd15), After Multiple Doses (PD-AUCd29) of Crizanlizumab at 5.0 mg/kg in Sickle Cell Disease (SCD) PatientsPrimary· 1st dose: Day 1: (pre-dose, 0.5, 1, 2, 4, 6 & 24 hours post dose, Days 4, 8, 15; 5th dose: Day 1(pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose), Days 4, 8, 15, 22 & 29
PD-AUCd15 and PD-AUCd29 were derived from the P-selectin inhibition data of week 1 and week 15, respectively.
To characterize PD of crizanlizumab at 5.0 mg/kg in SCD patients The area under the curve (AUC) of percentage of P-selectin inhibition versus time profile after the starting dose (PD-AUCd15) and after multiple doses (PD-AUCd29) is being reported.
Starting dose (Week 1): PD-AUCd15
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
33200
± 1830
Steady state (Week 15): PD-AUCd29
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
66900
± 5540
Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to Healthcare Visit in Clinic/Emergency Room (ER)/HospitalSecondary· Baseline (Week 1) through approx. 45 months (median exposure to treatment)
To assess the efficacy of crizanlizumab at 5.0 mg/kg and 7.5 mg/kg in Sickle cell disease (SCD) patients. Annualized rate of VOC=(Number of VOC reported until End date ×365.25)/(End date - date of first dose of study treatment+1).
End date is defined as the minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-glutamine or other therapies such as voxelotor and erythropoietin to treat SCD and or to prevent/reduce VOCs, cut-off date).
Baseline annualized rate of VOC
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
4.00
1.0 – 25.0
Crizanlizumab 7.5 mg/kg
2.00
1.0 – 9.0
Annualized rate of VOC on treatment
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
2.75
0.0 – 17.3
Crizanlizumab 7.5 mg/kg
0.97
0.0 – 7.9
Annualized Rate of VOC Events Treated at Home (Based on Documentation by Health Care Provider Following Phone Contact With Patient)Secondary· Baseline (Week 1) through approx. 45 months (median exposure to treatment)
To assess the efficacy of crizanlizumab at 5.0 mg/kg and 7.5 mg/kg in SCD patients. Annualized rate of VOC=(Number of VOC reported until End date ×365.25)/(End date - date of first dose of study treatment+1).
End date is defined as the minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-glutamine or other therapies such as voxelotor and erythropoietin to treat SCD and or to prevent/reduce VOCs, cut-off date).
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
0.68
0.21 – 2.17
Crizanlizumab 7.5 mg/kg
0.71
0.35 – 1.74
Annualized Rate of Total and VOC-related Hospitalizations and Emergency Room (ER) VisitsSecondary· Baseine (Week 1) through approx. 45 months (median exposure to treatment)
To assess the efficacy of crizanlizumab at 5.0 mg/kg and 7.5 mg/kg in SCD patients. Annualized rate of hospitalizations and ER visits = number of hospitalizations and ER visits reported until end date × 365.25/(End date - treatment start date + 1).
End date is defined as the minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-glutamine or other therapies such as voxelotor and erythropoietin to treat SCD and or to prevent/reduce VOCs, cut-off date).
Annualized rate (total)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
3.42
0.0 – 57.8
Crizanlizumab 7.5 mg/kg
2.47
0.0 – 8.1
Annualized rate (VOC related)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
3.34
0.0 – 57.8
Crizanlizumab 7.5 mg/kg
0.86
0.0 – 7.9
Hospitalizations/ER Annualized rate (total)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
2.46
0.0 – 22.1
Crizanlizumab 7.5 mg/kg
1.44
0.0 – 7.9
Hospitalizations/ER Annualized rate (VOC related)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
2.27
0.0 – 22.1
Crizanlizumab 7.5 mg/kg
0.48
0.0 – 7.9
Annualized Days of Total and VOC-related Hospitalizations and Emergency Room (ER) VisitsSecondary· Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Assess the efficacy of crizanlizumab at 5.0 mg/kg and 7.5 mg/kg in SCD patients for hospitalizations and ER visits. Annualized days of all hospitalizations and ER visits = Number of days of all hospitalizations and ER visits × 365.25/(End date - treatment start date + 1).
End date is defined as the minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-glutamine or other therapies such as voxelotor and to treat SCD and or to prevent/reduce VOCs, cut-off date).
Annualized days (total)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
11.95
0.0 – 86.2
Crizanlizumab 7.5 mg/kg
3.17
0.0 – 36.8
Annualized days (VOC related)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
9.03
0.0 – 86.2
Crizanlizumab 7.5 mg/kg
1.57
0.0 – 36.8
Hospitalizations/ER Annualized days (total)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
10.31
0.0 – 69.4
Crizanlizumab 7.5 mg/kg
2.57
0.0 – 36.8
Hospitalizations/ER Annualized days (VOC related)
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
7.27
0.0 – 69.4
Crizanlizumab 7.5 mg/kg
0.60
0.0 – 36.8
Annualized Rate of Each Subcategory of All VOC Events (Acute Chest Syndrome (ACS), Priapism, Uncomplicated Sickle Cell-vaso-occlusive Cisis (Uncomplicated SC-VOCs))Secondary· Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Assess the efficacy of crizanlizumab at 5.0 mg/kg and 7.5 mg/kg in SCD patients. The baseline (BL) annualized rate of VOC is defined as the number of VOCs reported in the last 12 months in the eCRF. Annualized rate of VOC=(Number of VOC reported until End date ×365.25)/(End date - date of first dose of study treatment+1).
End date is defined as the minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-glutamine or other therapies such as voxelotor and erythropoietin to treat SCD and or to prevent/reduce VOCs, cut-off date).
BL annualized rate of VOC: ACS
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
0.00
0.0 – 2.0
Crizanlizumab 7.5 mg/kg
0.00
0.0 – 2.0
Annualized rate of VOC on treatment: ACS
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
0.62
0.0 – 2.7
Crizanlizumab 7.5 mg/kg
0.25
0.0 – 0.6
BL annualized rate of VOC: Priapism
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
1.00
0.0 – 4.0
Annualized rate of VOC on treatment: Priapism
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
1.58
0.0 – 3.8
BL annualized rate of VOC: Uncomplicated SC-VOCs
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
3.00
1.0 – 25.0
Crizanlizumab 7.5 mg/kg
2.00
1.0 – 9.0
Annualized rate of VOC on treatment: Uncomplicated SC-VOCs
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
2.58
0.0 – 17.3
Crizanlizumab 7.5 mg/kg
1.04
0.0 – 7.9
Annualized Rate of VOC Events (Including Both Healthcare Visit and Home Treatment)Secondary· Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Assess the efficacy of crizanlizumab at 5.0 mg/kg and 7.5 mg/kg in SCD patients. Annualized rate of VOC=(Number of VOC reported until End date ×365.25)/(End date -date of first dose of study treatment+1).
End date is defined as th e minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-glutamine or other therapies such as voxelotor and erythropoietin to treat SCD and or to prevent/reduce VOCs, cut-off date).
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
3.42
0.0 – 17.3
Crizanlizumab 7.5 mg/kg
1.65
0.0 – 9.3
Number of Participants With Immunogenicity (IG) by Any Positive StatusSecondary· Baseline (Week 1), post-baseline (approx. 45 months (median exposure))
Assess safety and tolerability of crizanlizumab at 5.0 mg/kg and 7.5 mg/kg in SCD patients by the percentage of participants with any positive status. Immunogenicity is the measurement of anti-drug antibodies (ADA) to crizanlizumab.
Baseline: Positive
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
0
Crizanlizumab 7.5 mg/kg
0
All Participants
0
Post-Baseline: Any Positive
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
0
Crizanlizumab 7.5 mg/kg
0
All Participants
0
Percentage of P-selectin Inhibition Prior to Each Study Drug Dose of Crizanlizumab at 5.0 mg/kg in Sickle Cell Disease (SCD) PatientsPrimary· Pre-dose on Day 1 for Weeks 3, 7, 11, 15, 19, 23, 27, 31,35, 39, 43, 47, 51 (at 0 hr or pre-dose)
To characterize the PD effect of crizanlizumab in terms of Percentage of P-selectin inhibition prior to study drug dose at 5 mg/kg in CSD patients.
Week (W) 3 Day (D) 1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
97.3
± 7.49
W7D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
93.0
± 17.1
W11D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
87.8
± 22.6
W15D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
94.1
± 12.8
WD19: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
91.7
± 18.5
W23D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
93.2
± 14.9
W27D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
94.3
± 13.0
W31D1: 0 hrs pre-dose
Group
Value
95% CI
Crizanlizumab 5.0 mg/kg
92.4
± 18.9
Adverse events — posted to ClinicalTrials.gov
Time frame: All deaths, Serious Adverse Events, and Other Adverse Events for both 'Treatment phase' and 'Post-treatment follow-up phase' (up to 105 days after the last dose of study treatment) were reported. The median duration of exposure to crizanlizumab was 206.1 weeks in the 5.0 mg/kg dose group and 169.6 weeks in the 7.5 mg/kg dose group..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04662931 — An Indian Multi-centric Phase IV Study to Assess the Safety of Crizanlizumab in Sickle Cell Disease Patients
· Phase 4
· completed
NCT03720626 — Managed Access Programs for SEG101, Crizanlizumab
· available
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 9 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03264989.