A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
Age: 12 - 55 years
Healthy Subjects: No
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: March 09, 2022
End Date: January 10, 2025
Reference Study ID Number
888-662-6728 (U.S. and Canada) 888-662-6728 (U.S. and Canada)
- Body weight >=40 kg.
- Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (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.
- 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 <6 g/dL.
- Known or suspected hereditary complement deficiency.
- Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration.
- Presence of fever (>=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. meningitidis infection within the prior 6 months.
- Anemia, Sickle Cell