A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allakos Inc.
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Total Polys Score (TPS)
研究概览
简要总结
This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.
详细描述
AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale
- •History of sinusitis symptoms
- •SNOT-22 ≥30
- •No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings
排除标准
- •Use of systemic corticosteroids within 6 weeks of screening
- •Chronic use of antibiotic therapy within 3 months prior to Screening
- •Nasal surgery (including polypectomy) within 6 months prior to Screening
- •Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer
研究组 & 干预措施
25 mg AK001
25 mg AK001 will be administered as multiple doses
干预措施: AK001 low dose (Drug)
250 mg AK001
250 mg AK001 will be administered as multiple doses
干预措施: AK001 high dose (Drug)
Placebo
A placebo comparator consisting of inactive excipients will be administered as multiple doses
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Polys Score (TPS)
时间窗: From Baseline (prior to the first dose) to Week 12 (Day 84)
NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Change in TPS from Baseline (prior to the first dose) to Week 12 (Day 84) was the primary outcome of the study. TPS ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps, a higher scores mean a worse outcome.
次要结局
未报告次要终点