Sickle Cell Disease
Conditions
Brief summary
Number and percentage of subjects with Treatment Emergent Adverse Events (TEAEs), overall and by severity, seriousness and relationship to Investigational Product (IP), Number and percentage of subjects with Adverse Events of Special Interest (AESIs), Clinically relevant changes from baseline in laboratory assessments and vital signs
Detailed description
From the first dose of anumigilimab through Week 65: • Serum anumigilimab, During the 52-week Maintenance Period: • Annualized rate of Vaso-occlusive crisis (VOC) (medical facility)
Interventions
DRUGAnumigilimab
DRUGSaline 0.9%
Sponsors
CSL Behring LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of subjects with Treatment Emergent Adverse Events (TEAEs), overall and by severity, seriousness and relationship to Investigational Product (IP), Number and percentage of subjects with Adverse Events of Special Interest (AESIs), Clinically relevant changes from baseline in laboratory assessments and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| From the first dose of anumigilimab through Week 65: • Serum anumigilimab, During the 52-week Maintenance Period: • Annualized rate of Vaso-occlusive crisis (VOC) (medical facility) | — |
Outcome results
None listed