A Phase 2 interventional study of crizanlizumab in Sickle Cell Disease (SCD), sponsored by Novartis Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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 complete full Pharmacokinetic/Pharmacodynamic (PK/PD) sampling at week 1 and week 15. In all patients, trough PK/PD samples were collected prior to each dose. In addition, throughout the study (and when possible), all patients had blood drawn for serum to assess PK and PD drawn at times of onset and resolution of each VOC event, fever, or infection. Once the up to 45 patients were enrolled, 12 additional patients were enrolled to the exploratory treatment group and began at 7.5 mg/kg of crizanlizumab.
The study was initiated on 19-Dec-2017. This study provides five years follow up data that fully characterizes the safety, tolerability and treatment effect of the 5.0 mg/kg and 7.5 mg/kg doses of crizanlizumab along with the initially planned PK and PD data.
At the time of study closure, crizanlizumab 5.0 mg/kg was an FDA approved treatment in the United States (US) for patients with sickle-cell disease. Therefore, the patients treated with crizanlizumab 5.0 mg/kg dose were encouraged to transition to commercial supply of crizanlizumab. The patients treated with the not currently approved dose of crizanlizumab 7.5 mg/kg were allowed to join a multi-center, multi-national, rollover clinical trial (Study SEG101A2401B), for continued access to treatment with crizanlizumab.
Exclusion Criteria:
SEG101 (crizanlizumab) drug at a dose of 5.0 mg/kg (or 7.5 mg/kg for exploratory group) by IV infusion.
Drug: crizanlizumab
Crizanlizumab was administered IV infusion over 30 minutes at the assigned dose on Week 1 Day 1, Week 3 Day 1, and then Day 1 of every 4-week cycle. Cycle = 28 days
Also known as: SEG101
Pharmacokinetic (PK): AUCd15 and AUCtau of Crizanlizumab at 5.0 mg/kg in Sickle Cell Disease (SCD) Patients
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)
Time frame: 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
PK: Cmax of Crizanlizumab at 5.0 mg/kg in Sickle Cell Disease (SCD) Patients
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).
Time frame: After the starting dose (Week 1) and after multiple doses (steady state, Week 15)
Pre-dose Concentrations Prior to Each Study Drug Dose
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.
Time frame: Pre-dose at Day 1 on Weeks 3, 7, 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, 51
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) Patients
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.
Time frame: 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
Percentage of P-selectin Inhibition Prior to Each Study Drug Dose of Crizanlizumab at 5.0 mg/kg in Sickle Cell Disease (SCD) Patients
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.
Time frame: 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)
Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to Healthcare Visit in Clinic/Emergency Room (ER)/Hospital
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).
Time frame: Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Annualized Rate of VOC Events Treated at Home (Based on Documentation by Health Care Provider Following Phone Contact With Patient)
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).
Time frame: Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Annualized Rate of Total and VOC-related Hospitalizations and Emergency Room (ER) Visits
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).
Time frame: Baseine (Week 1) through approx. 45 months (median exposure to treatment)
Annualized Days of Total and VOC-related Hospitalizations and Emergency Room (ER) Visits
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).
Time frame: Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Annualized Rate of Each Subcategory of All VOC Events (Acute Chest Syndrome (ACS), Priapism, Uncomplicated Sickle Cell-vaso-occlusive Cisis (Uncomplicated SC-VOCs))
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).
Time frame: Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Annualized Rate of VOC Events (Including Both Healthcare Visit and Home 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).
Time frame: Baseline (Week 1) through approx. 45 months (median exposure to treatment)
Number of Participants With Immunogenicity (IG) by Any Positive Status
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.
Time frame: Baseline (Week 1), post-baseline (approx. 45 months (median exposure))
57 patients were enrolled sequentially to study the at 5 mg/kg arm and at 7.5 mg/kg.
| Milestone | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg |
|---|---|---|
| Started | 45 | 12 |
| Completed | 0 | 0 |
| Not completed | 45 | 12 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: New therapy for study indication | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Patient decision | 13 | 0 |
| Withdrew: Physician decision | 6 | 4 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Pregnancy | 2 | 0 |
| Withdrew: End of study | 19 | 5 |
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)
| hr*μg/mL | Crizanlizumab 5.0 mg/kg |
|---|---|
| Starting dose (Week 1): AUCd15 | 13100 ± 2810 |
| Steady State (Week 15): AUCtau | 20800 ± 5030 |
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).
| μg/mL | Crizanlizumab 5.0 mg/kg |
|---|---|
| Starting dose (Week 1) | 102 ± 29.8 |
| Steady State (Week 15) | 123 ± 36.4 |
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.
| μg/mL | Crizanlizumab 5.0 mg/kg |
|---|---|
| Week (W) 3 Day 1 (D)1: 0 hrs pre-dose | 18.0 ± 6.42 |
| W7 D1: 0 hrs pre-dose | 10.8 ± 5.21 |
| W11 D1: 0 hrs pre-dose | 9.04 ± 5.04 |
| W15 D1: 0 hrs pre-dose | 10.0 ± 5.39 |
| W19 D1: 0 hrs pre-dose | 9.37 ± 4.95 |
| W23 D1: 0 hrs pre-dose | 9.91 ± 5.09 |
| W27 D1: 0 hrs pre-dose | 9.65 ± 4.03 |
| W31 D1: 0 hrs pre-dose | 9.75 ± 4.66 |
| W35 D1: 0 hrs pre-dose | 9.48 ± 4.60 |
| W39 D1: 0 hrs pre-dose | 9.54 ± 5.47 |
| W43 D1: 0 hrs pre-dose | 8.53 ± 5.24 |
| W47 D1: 0 hrs pre-dose | 8.96 ± 4.31 |
| W51 D1: 0 hrs pre-dose | 8.45 ± 4.88 |
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.
| hours*% of P-selectin inhibition | Crizanlizumab 5.0 mg/kg |
|---|---|
| Starting dose (Week 1): PD-AUCd15 | 33200 ± 1830 |
| Steady state (Week 15): PD-AUCd29 | 66900 ± 5540 |
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).
| number of events per year | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg |
|---|---|---|
| Baseline annualized rate of VOC | 4.00 (1.0 to 25.0) | 2.00 (1.0 to 9.0) |
| Annualized rate of VOC on treatment | 2.75 (0.0 to 17.3) | 0.97 (0.0 to 7.9) |
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).
| number of events per participant-year | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg |
|---|---|---|
| Annualized Rate of VOC Events Treated at Home (Based on Documentation by Health Care Provider Following Phone Contact With Patient) | 0.68 (0.21 to 2.17) | 0.71 (0.35 to 1.74) |
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).
| number of events per participant-year | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg |
|---|---|---|
| Annualized rate (total) | 3.42 (0.0 to 57.8) | 2.47 (0.0 to 8.1) |
| Annualized rate (VOC related) | 3.34 (0.0 to 57.8) | 0.86 (0.0 to 7.9) |
| Hospitalizations/ER Annualized rate (total) | 2.46 (0.0 to 22.1) | 1.44 (0.0 to 7.9) |
| Hospitalizations/ER Annualized rate (VOC related) | 2.27 (0.0 to 22.1) | 0.48 (0.0 to 7.9) |
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).
| number of days per year | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg |
|---|---|---|
| Annualized days (total) | 11.95 (0.0 to 86.2) | 3.17 (0.0 to 36.8) |
| Annualized days (VOC related) | 9.03 (0.0 to 86.2) | 1.57 (0.0 to 36.8) |
| Hospitalizations/ER Annualized days (total) | 10.31 (0.0 to 69.4) | 2.57 (0.0 to 36.8) |
| Hospitalizations/ER Annualized days (VOC related) | 7.27 (0.0 to 69.4) | 0.60 (0.0 to 36.8) |
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).
| number of events per year | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg |
|---|---|---|
| BL annualized rate of VOC: ACS | 0.00 (0.0 to 2.0) | 0.00 (0.0 to 2.0) |
| Annualized rate of VOC on treatment: ACS | 0.62 (0.0 to 2.7) | 0.25 (0.0 to 0.6) |
| BL annualized rate of VOC: Priapism | 1.00 (0.0 to 4.0) | — |
| Annualized rate of VOC on treatment: Priapism | 1.58 (0.0 to 3.8) | — |
| BL annualized rate of VOC: Uncomplicated SC-VOCs | 3.00 (1.0 to 25.0) | 2.00 (1.0 to 9.0) |
| Annualized rate of VOC on treatment: Uncomplicated SC-VOCs | 2.58 (0.0 to 17.3) | 1.04 (0.0 to 7.9) |
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).
| number of events per year | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg |
|---|---|---|
| Annualized Rate of VOC Events (Including Both Healthcare Visit and Home Treatment) | 3.42 (0.0 to 17.3) | 1.65 (0.0 to 9.3) |
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.
| Participants | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg | All Participants |
|---|---|---|---|
| Baseline: Positive | 0 | 0 | 0 |
| Post-Baseline: Any Positive | 0 | 0 | 0 |
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.
| percentage of P-selectin inhibition | Crizanlizumab 5.0 mg/kg |
|---|---|
| Week (W) 3 Day (D) 1: 0 hrs pre-dose | 97.3 ± 7.49 |
| W7D1: 0 hrs pre-dose | 93.0 ± 17.1 |
| W11D1: 0 hrs pre-dose | 87.8 ± 22.6 |
| W15D1: 0 hrs pre-dose | 94.1 ± 12.8 |
| WD19: 0 hrs pre-dose | 91.7 ± 18.5 |
| W23D1: 0 hrs pre-dose | 93.2 ± 14.9 |
| W27D1: 0 hrs pre-dose | 94.3 ± 13.0 |
| W31D1: 0 hrs pre-dose | 92.4 ± 18.9 |
| W35D1: 0 hrs pre-dose | 91.7 ± 14.7 |
| W39D1: 0 hrs pre-dose | 88.5 ± 21.2 |
| W43D1: 0 hrs pre-dose | 86.1 ± 24.8 |
| W47D1: 0 hrs pre-dose | 92.1 ± 16.8 |
| W51D1: 0 hrs pre-dose | 91.5 ± 17.6 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Crizanlizumab 5.0 mg/kg | 1/45 (2.2%) | 22/45 (48.9%) | 42/45 (93.3%) |
| Crizanlizumab 7.5 mg/kg | 1/12 (8.3%) | 6/12 (50%) | 11/12 (91.7%) |
| All Participants | 2/57 (3.5%) | 28/57 (49.1%) | 53/57 (93%) |
| Event | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg | All Participants |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/45 | 1/12 | 1/57 |
| CytopeniaBlood and lymphatic system disorders | 0/45 | 1/12 | 1/57 |
| Cardiac arrestCardiac disorders | 0/45 | 1/12 | 1/57 |
| PyrexiaGeneral disorders | 1/45 | 1/12 | 2/57 |
| CholelithiasisHepatobiliary disorders | 0/45 | 1/12 | 1/57 |
| HypertransaminasaemiaHepatobiliary disorders | 0/45 | 1/12 | 1/57 |
| Ischaemic hepatitisHepatobiliary disorders | 0/45 | 1/12 | 1/57 |
| Anaphylactic reactionImmune system disorders | 0/45 | 1/12 | 1/57 |
| AppendicitisInfections and infestations | 0/45 | 1/12 | 1/57 |
| COVID-19Infections and infestations | 3/45 | 1/12 | 4/57 |
| Event | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg | All Participants |
|---|---|---|---|
| PyrexiaGeneral disorders | 13/45 | 3/12 | 16/57 |
| HypokalaemiaMetabolism and nutrition disorders | 12/45 | 2/12 | 14/57 |
| HeadacheNervous system disorders | 12/45 | 2/12 | 14/57 |
| VomitingGastrointestinal disorders | 4/45 | 3/12 | 7/57 |
| Upper respiratory tract infectionInfections and infestations | 10/45 | 2/12 | 12/57 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/45 | 2/12 | 10/57 |
| ConstipationGastrointestinal disorders | 3/45 | 2/12 | 5/57 |
| DiarrhoeaGastrointestinal disorders | 4/45 | 2/12 | 6/57 |
| NauseaGastrointestinal disorders | 6/45 | 2/12 | 8/57 |
| Ocular icterusHepatobiliary disorders | 1/45 | 2/12 | 3/57 |
Full Analysis Set (FAS): Consisted of all patients to whom crizanlizumab had been assigned and who received at least 1 dose of study treatment.
| Age, Continuous(years) | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg | Total |
|---|---|---|---|
| Mean | 32.3 ± 12.71 | 26.8 ± 12.25 | 31.2 ± 12.71 |
| Age, Customized(participants) | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg | Total |
|---|---|---|---|
| 16 - < 18 years | 1 | 2 | 3 |
| 18 - < 65 years | 43 | 10 | 53 |
| 65 - < 70 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg | Total |
|---|---|---|---|
| Female | 25 | 6 | 31 |
| Male | 20 | 6 | 26 |
| Race/Ethnicity, Customized(participants) | Crizanlizumab 5.0 mg/kg | Crizanlizumab 7.5 mg/kg | Total |
|---|---|---|---|
| Black or African American | 44 | 12 | 56 |
| White and Black or African American | 1 | 0 | 1 |
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