NCT05695248已完成1 期
A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants With Hereditary Angioedema (The ALPHA-STAR Trial)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 40
- 主要终点
- Number of Participants Experiencing Treatment-emergent Adverse Events
研究概览
简要总结
The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.
详细描述
This is a Phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of navenibart in participants with type I or type II HAE in 3 dose cohorts. The first cohort will receive 1 dose of navenibart; the second and third cohorts will receive 2 sequential doses. This is the first trial of navenibart in participants with HAE and the first evaluation of a multiple-dose regimen. After the required follow up period, participants who are willing and eligible to consent can begin participation in the long-term open label extension study (STAR-0215-202, ALPHA-SOLAR; NCT06007677).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of HAE (type I or II). The following must be met:
- •a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
- •Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
排除标准
- •Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
- •Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
- •lanadelumab within 90 days
- •berotralstat within 21 days
- •all other prophylactic therapies, within 7 days
- •Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening.
- •Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
结局指标
主要结局
Number of Participants Experiencing Treatment-emergent Adverse Events
时间窗: Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), and Day 475 (Cohort 3)
次要结局
- Change From Baseline in Monthly HAE Attack Rate(Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3))
- Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy(Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195)
- Number of Participants with Anti-drug Antibodies To STAR-0215(Cohort 1: Day 1 (pre-dose); Days 14, 28, 56, 84, 112, 140, and 168; Cohort 2: Days 1 and 84 (pre-dose); Days 14, 28, 56, 111, 167, and 251; Cohort 3: Days 1 and 28 (pre-dose); Days 14, 55, 111, and 195)
- Serum Concentration of STAR-0215(Cohort 1: Day 1 (pre-dose, 4 hours post dose) up to Day 168; Cohort 2: Days 1 and 84 (pre-dose, 4 hours post dose) up to Day 251; Cohort 3: Days 1 and 28 (pre-dose, 4 hours post dose) up to Day 195)
- Duration of HAE Attacks(Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195)
- Severity of HAE Attacks Experienced by Participants(Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195)
- Plasma Levels of Cleaved High-molecular-weight Kininogen(Cohort 1: Day 1 (pre-dose, 4 hours post dose) up to Day 168; Cohort 2: Days 1 and 84 (pre-dose, 4 hours post dose) up to Day 251; Cohort 3: Days 1 and 28 (pre-dose, 4 hours post dose) up to Day 195)
- Time to First HAE Attack After First and Last Dosing(Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195)
研究者
研究点 (40)
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相关资讯
Navenibart Shows Promise in Reducing Hereditary Angioedema Attacks in Phase 1b/2 Trial- Interim analysis of the ALPHA-STAR trial demonstrates navenibart's effectiveness in reducing hereditary angioedema attacks, with complete elimination of severe attacks at both 3- and 6-month follow-ups.
- The study showed significant reduction in monthly attack rates requiring rescue medication, from 1.86 to 0.16 at 3 months and 1.32 to 0.10 at 6 months post-treatment.
- The drug demonstrated a favorable safety profile with no serious treatment-emergent adverse events or discontinuations reported during the trial period.last yearAstria Therapeutics Plans Phase 3 Trial of Navenibart for Hereditary Angioedema- Astria Therapeutics is set to launch a Phase 3 clinical trial for navenibart in early 2025, evaluating different dosing schedules for hereditary angioedema (HAE).
- Navenibart, a kallikrein inhibitor, aims to reduce bradykinin production and prevent swelling attacks in HAE patients, with dosing options every three or six months.
- Positive interim results from the Phase 1b/2 ALPHA-STAR trial showed over 90% reduction in swelling attacks, with final data expected by the end of 2024.
- Navenibart has received orphan drug status from the FDA and orphan medicinal product designation in Europe, providing market exclusivity incentives.last year