NCT06007677进行中（未招募）2 期
A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients With Hereditary Angioedema (The ALPHA-SOLAR Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 22
- 主要终点
- Number of Participants Experiencing Treatment-emergent Adverse Events
研究概览
简要总结
The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
- •Completed STAR-0215-201 (follow up through 6 months after their last dose);
- •Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
- •Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
- •Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor).
排除标准
- •Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
- •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.
- •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, discuss with the Medical Monitor
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Dose Regimen 1 (Arm A): STAR-0215
Experimental
Participants will receive STAR-0215 every 3 months.
干预措施: STAR-0215 (Drug)
Dose Regimen 2 (Arm B): STAR-0215
Experimental
Participants will receive STAR-0215 every 6 months.
干预措施: STAR-0215 (Drug)
Dose Regimen 1 (Arm C): STAR-0215
Experimental
STAR-0215 will be administered as a subcutaneous injection.
干预措施: STAR-0215 (Drug)
Dose Regimen 3 (Arm D): STAR-0215
Experimental
STAR-0215 will be administered as a subcutaneous injection.
干预措施: STAR-0215 (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment-emergent Adverse Events
时间窗: Day 1 through study completion, an average of 6 years
次要结局
- Change From Baseline in Monthly HAE Attack Rate(Day 1, up to 5 years)
- Severity of HAE Attacks Experienced by Participants(Day 1 through up to 5 years)
- Duration of HAE Attacks(Day 1 through up to 5 years)
- Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy(Day 1 through up to 5 years)
- Time to First HAE Attack After Each Dose(Day 1 through up to 5 years)
- Number of HAE Attack-free Days(Day 1 through up to 5 years)
- Number of Participants Experiencing Zero HAE Attacks(Day 1 through up to 5 years)
- Serum Concentration of STAR-0215(Every 3 months for first 2 years, Every 6 months for next 3 years)
- Plasma Levels of Cleaved High-molecular-weight Kininogen(Every 3 months for first 2 years, Every 6 months for next 3 years)
- Number of Participants with Anti-drug Antibodies to STAR-0215(Every 3 months for first 2 years, Every 6 months for next 3 years)
研究者
研究点 (22)
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