Haematological Disorders
Conditions
Interventions
Placebo
Sponsors
Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Body weight >=40 kg. - Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia). - Two or more (>=2) to <=10 documented VOEs in the 12 months prior to randomisation. - If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons. - If receiving erythropoietin, the participant must have been prescribed this medication for the preceding 3 months and be dose-stabilised for at least 3 months prior to study enrollment. - Vaccination against N. meningitides serotypes A, C, W, and Y and Vaccinations against H. influenza type B and S. pneumonia. - Participants who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation. - Adequate hepatic and renal function. - For women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of study treatment.
Exclusion criteria
Exclusion criteria: - History of hematopoietic stem cell transplant. - Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study. - History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment. - Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial. - Hemoglobin =38 degrees Celsius) within 7 days before the first drug administration. - Immunised with a live attenuated vaccine within 1 month before first drug administration. - Pregnant or breastfeeding, or intending to become pregnant during the study or within 10.5 months after the final dose of study treatment. - Known HIV infection with documented CD4 count <200 cells/microliter within 24 weeks prior to screening. - History of N. meningitis infection within the prior 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Annualized rate of medical facility VOEs (AVR) [ Time Frame: Baseline up to Week 49 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| - Annualized rate of home VOE [ Time Frame: Baseline up to Week 49 ] - Annualized rate of uncomplicated medical facility VOE [ Time Frame: Baseline up to Week 49 ] - Annualized rate of Acute Chest Syndrome (ACS) [ Time Frame: Baseline to up Week 49 ] - Annualized rate of days hospitalized for medical facility VOE [ Time Frame: Baseline up to Week 49 ] - Annualized rate of days hospitalized for treatment of non-VOE complications of SCD [ Time Frame: Baseline up to Week 49 ] - Time to first medical facility VOE from randomization [ Time Frame: Baseline up to Week 49 ] - Change in urinary albumin-creatinine ratio [ Time Frame: Baseline up to Week 49 ] - Change in Tricuspid Regurgitant Jet Velocity (TRV) [ Time Frame: Baseline up to Week 49 ] - Percentage of Participants with TRV >2.5 m/s [ Time Frame: Week 49 ] - Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Score in Adults [ Time Frame: Baseline up to Week 49 ] - Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 91 weeks ] - Serum Concentrations of Crovalimab over time [ Time Frame: Baseline up to Week 49 ] - Percentage of Participants with Anti-Drug Antibodies to Crovalimab [ Time Frame: Baseline up to Week 49 ] | — |
Countries
Kenya
Contacts
Public ContactEileen Koske
Clinical Operations Lead
Outcome results
None listed