A phase 1B randomized, placebo-controlled study evaluating the safety, pharmacokinetics, pharmacodynamics, and efficacy of crovalimab for the management of acute uncomplicated vaso-occlusive episodes (voe) in patients with Sickle Cell Disease (SCD)

Roche0 个研究点目标入组 30 人开始时间: 2023年7月24日最近更新: 2024年3月4日

研究概览

暂无简介。

•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.

•-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.

发起方