The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Crovalimab will be administered as a single dose of 1000 milligrams (mg) IV (for participants with a body weight between 40 kilograms (kg) and 100 kg) or 1500 mg IV (for participants with a body weight \>=100 kg).
Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab
Children'S Healthcare of Atlanta
Atlanta, Georgia, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
CHU Henri Mondor
Créteil, France
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi
Verona, Veneto, Italy
International Cancer Institute (ICI)
Eldoret, Kenya
Gertrude's Children Hospital
Nairobi, Kenya
American University of Beirut - Medical Center
Beirut, Lebanon
Hopital Nini
Tripoli, Lebanon
...and 6 more locations
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to Day 84
Percentage of Participants with Infusion-Related Reactions and Hypersensitivity
Time frame: Baseline up to Day 84
Time to Improvement of the Primary Acute Uncomplicated VOE From Baseline
Time frame: Baseline up to Day 84
Total Cumulative Opioid Dose From Baseline
Time frame: Baseline up to Day 84
Time to Discontinuation of all Parenteral Opioids From Baseline
Time frame: Baseline up to Day 84
Time to Readiness For Hospital Discharge From Baseline
Time frame: Baseline up to Day 84
Time to Hospital Discharge From Baseline
Time frame: Baseline up to Day 84
Time to a Confirmed Decrease in Pain Score of at Least 2 Points From the Maximal Pre-dose Pain Score
Time frame: Baseline up to Day 84
Change in Pain Score From the Maximal Pre-dose Pain Score to the Score at Hospital Discharge
Time frame: Baseline up to Day 84
Percentage of Participants who Develop Acute Chest Syndrome (ACS)
Time frame: Baseline up to Day 28
Percentage of Participants Requiring Intensive Care Unit (ICU)/Critical Care Admission for SCD-related Complications
Time frame: Baseline up to Day 84
Percentage of Participants Requiring Blood Transfusion for SCD-related Complications
Time frame: Baseline up to Day 84
Readmission Rate for a VOE or VOE-related Event Within 28 days of Discharge of the Primary Acute Uncomplicated VOE
Time frame: Baseline up to Day 84
Serum Concentrations of Crovalimab Over Time
Time frame: Baseline up to Day 84
Change in PD Biomarkers Including Complement Activity (CH50) Over Time
Assessed by a Liposome Immunoassay (LIA)
Time frame: Baseline up to Day 84
Change Over Time in Free C5 Concentration
Time frame: Baseline up to Day 84
Change Over Time in Soluble Complement 5b 9 (sC5b-9) Concentration
Time frame: Baseline up to Day 84
Percentage of Participants with Anti-Drug Antibodies to Crovalimab
Time frame: Baseline up to Day 84
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.