Haematological Disorders
Conditions
Interventions
Placebo
Sponsors
Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Body weight >=40 kg. -Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia). --Vaccination against Neisseria Meningitidis serotypes A, C, W, and Y. Vaccinations against H. influenzae type B and S. pneumoniae. -Participants vaccinated against SARS-CoV-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine. -Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics. -Adequate hepatic and renal function. -Hemoglobin >=5 grams/deciliter (g/dL) -Platelet count >=100,000/microliter (µL) -Participants receiving sickle cell therapies must be on a stable dose for >=28 days. -For female participants of childbearing potential, an agreement to remain abstinent or use contraception for 322 days (approximately 10.5 months) after the dose of study treatment.
Exclusion criteria
Exclusion criteria: -More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit. -Pain related to the current VOE ongoing for >48 hours. -Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism. -Pain atypical of an acute uncomplicated VOE. -Evidence of or suspicion of ACS. -Evidence or high suspicion of a severe systemic infection. -Major surgery and/or hospitalization for any reason within 30 days. -History of Neisseria meningitidis infection within 6 months prior. -Known HIV infection with a documented CD4 count <200 cells/µL. -Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol. -Immunized with a live attenuated vaccine within 30 days. -History of hematopoietic stem cell transplant. -Known or suspected hereditary complement deficiency. -Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration. -Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Day 322 ] -Percentage of Participants with Infusion-Related Reactions and Hypersensitivity [ Time Frame: Baseline up to Day 84 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| -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 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 [ Time Frame: Baseline up to Day 84 ] Assessed by a Liposome Immunoassay (LIA) -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 ] | — |
Countries
Kenya
Contacts
Public ContactEileen Koske
Clinical Operations Lead
Outcome results
None listed