A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: March 26, 2022
End Date: July 14, 2025
Reference Study ID Number
888-662-6728 (U.S. and Canada)
888-662-6728 (U.S. and Canada)
Inclusion Criteria:
- Body weight >=40 kg.
- Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (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:
- 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.
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Conditions:
- Anemia, Sickle Cell