Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 15
- 主要终点
- Number and percentage of subjects with Treatment Emergent Adverse Events (TEAEs), overall and by severity, seriousness and relationship to Investigational Product (IP)
研究概览
简要总结
The primary objective of this study is to assess the safety of anumigilimab in adults with SCD
研究设计
- 分配方式
- Randomized
- 主要目的
- Maintenance period
- 盲法
- Double (Subject, Carer, Investigator, Monitor, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults aged greater than or equal to (>=) 18 years on the day of signing the informed consent form.
- •Confirmed diagnosis of SCD of any genotype.
- •Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening.
- •HU Regimen: a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening. or b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).
排除标准
- •Absolute neutrophil count less than (<) 2.5 ×10^9 cells/Litre at Screening or Baseline (Week 1 Day 1).
- •If on SCD preventive medication, dose is not stable in the 30 days before Screening.
- •History of myeloproliferative disorder or malignancy (other than skin cancer) within 5 years before Screening.
- •History of stem cell transplant or gene therapy.
- •Hemoglobin < 6.5 g/dL at Screening or Baseline (Week 1 Day 1).
研究组 & 干预措施
Saline 0.9%
干预措施: Saline 0.9% (Drug)
Anumigilimab
干预措施: Anumigilimab (Drug)
结局指标
主要结局
Number and percentage of subjects with Treatment Emergent Adverse Events (TEAEs), overall and by severity, seriousness and relationship to Investigational Product (IP)
Number and percentage of subjects with Treatment Emergent Adverse Events (TEAEs), overall and by severity, seriousness and relationship to Investigational Product (IP)
Number and percentage of subjects with Adverse Events of Special Interest (AESIs)
Number and percentage of subjects with Adverse Events of Special Interest (AESIs)
Clinically relevant changes from baseline in laboratory assessments and vital signs
Clinically relevant changes from baseline in laboratory assessments and vital signs
次要结局
- From the first dose of anumigilimab through Week 65: • Serum anumigilimab
- During the 52-week Maintenance Period: • Annualized rate of Vaso-occlusive crisis (VOC) (medical facility)
研究者
Study Director
Scientific
CSL Behring LLC