NCT04656418已完成3 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 64
- 试验地点
- 28
- 主要终点
- Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period
研究概览
简要总结
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.
- •Note: For subjects taking any prophylactic HAE therapy during the 3 months before Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing the prophylactic therapy.
排除标准
- •Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
研究组 & 干预措施
CSL312
Experimental
Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg subcutaneous (SC) injections, once monthly from Months 2 to 6.
干预措施: CSL312 (Biological)
Placebo
Placebo Comparator
Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.
干预措施: Placebo (Drug)
结局指标
主要结局
Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period
时间窗: First injection up to 6 months
Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \[number of HAE attacks / length of participant treatment in days\] \* 30.4375.
次要结局
- Time-Normalized Number of HAE Attacks Per Month Requiring On-Demand Treatment(6 months, first 3-months and second 3-months of treatment period)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as Treatment Emergent Adverse Events (TEAEs)(From first dose of study drug up to 3 months after the last injection (approximately 8 months))
- Time-normalized Number of HAE Attacks Per Month in the First 3-months and Second 3-months of Treatment Period(First 3-months and second 3-months of treatment period)
- Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AEs of Special Interest (AESI)(From first dose of study drug up to 3 months after the last injection (approximately 8 months))
- Number of Participants With CSL312-induced Anti-CSL312 Antibodies(Up to 8 months)
- Percentage Change in the Time-normalized Number of HAE Attacks Per Month During the Treatment Period Compared to the Run-in Period(6 months, first 3-months and second 3-months of treatment period)
- Time-Normalized Number of Moderate or Severe HAE Attacks Per Month(6 months, first 3-months and second 3-months of treatment period)
- Percentage of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as TEAEs(From first dose of study drug up to 3 months after the last injection (approximately 8 months))
- Relative Difference in Means in the Time-Normalized Number of HAE Attacks Per Month Between CSL312 to Placebo(6 months, first 3-months and second 3-months of treatment period)
- Percentage of Participants With a Response to Subject's Global Assessment of Response to Therapy (SGART)(Up to 6 months)
- Percentage of Participants With at Least One AE, SAE, and AESI(From first dose of study drug up to 3 months after the last injection (approximately 8 months))
- Percentage of Participants With CSL312-induced Anti-CSL312 Antibodies(Up to 6 months)
研究者
研究点 (28)
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