A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)
研究概览
简要总结
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
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, Care Provider, Investigator)
盲法说明
This will be a double-blind study.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Depemokimab
Participants received a 100 milligram (mg) dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52 weeks. Participants were to be maintained on their existing baseline maintenance for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) standard of care (SOC) treatment throughout the study.
干预措施: Depemokimab (GSK3511294) (Biological)
Placebo
Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52 weeks. Participants were to be maintained on their existing baseline maintenance for CRSwNP SOC treatment throughout the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)
时间窗: Baseline (Day 1) and at Week 52
Total endoscopic nasal polyps (NP) score evaluated the size and extent of nasal polyps via endoscopy. The assessments were performed by central video image recordings of nasal endoscopy. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores were graded based on NP size, recorded as sum of the right and left nostril scores and ranges from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril; with higher scores indicating worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Week 49 Through to Week 52
时间窗: Baseline (Day 1) and from Week 49 to Week 52
This endpoint evaluated the change from baseline in the mean nasal obstruction score using a Verbal Response Scale (VRS) from Week 49 through to Week 52. Participants used a VRS to rate nasal obstruction severity, with scores averaged over the specified period to assess treatment impact on nasal obstruction symptoms. Participants were asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals were calculated and data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of electronic diary (eDiary) data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
次要结局
- Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52(Baseline (Day 1) and from Week 49 to Week 52)
- Change From Baseline in Mean Symptom Score for Loss of Smell Using Verbal Response Scale From Week 49 Through to Week 52(Baseline (Day 1) and from Week 49 to Week 52)
- Change From Baseline in Lund Mackay Computerized Tomography (CT) Score at Week 52(Baseline (Day 1) and at Week 52)
- Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52(Baseline (Day 1) and at Week 52)
- Change From Baseline in Mean Nasal Obstruction Score (Verbal Response Scale) From Week 21 Through to Week 24(Baseline (Day 1) and from Week 21 to Week 24)
- Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 26(Baseline (Day 1) and at Week 26)
- Percentage of Participants Requiring First Nasal Surgery (Actual or Entry on Waiting List) or Disease-Modulating Medication for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Up to Week 52(Up to Week 52)
- Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP up to Week 52(Up to Week 52)
- Percentage of Participants Requiring at Least One Course of Systemic Corticosteroids or Disease-Modulating Medication for CRSwNP or Nasal Surgery (Actual) During the Week 52 Treatment Period(Up to Week 52)
- Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 52(Baseline (Day 1) and at Week 52)