2022-502546-26-00招募中1 期
A Phase IB, 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)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
研究概览
简要总结
To evaluate the safety of crovalimab compared with placebo
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety follow up
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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,, and vaccinations against H. influenzae type B and S. pneumoniae
- •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
- •Participants receiving sickle cell therapies must be on a stable dose for >=28 days
排除标准
- •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, and pain atypical of an acute uncomplicated VOE
- •Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol
- •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
结局指标
主要结局
Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
Change from baseline in targeted vital signs and clinical laboratory test results
Change from baseline in targeted vital signs and clinical laboratory test results
Incidence and severity of infusion-related reactions and hypersensitivity
Incidence and severity of infusion-related reactions and hypersensitivity
次要结局
- Serum concentrations of crovalimab over time
- Change over time in PD biomarkers (CH50, free C5, sC5b-9)
- Relationships between drug exposure and pharmacodynamics, efficacy, or safety endpoints of crovalimab (patients randomized to crovalimab)
- Time to improvement of the primary acute uncomplicated VOE from baseline
- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (7)
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