NCT07782957招募中3 期
A Randomized, Double-blind, Parallel Group Phase 3 Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (PERSIST CRSwNP-2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age and older
- •Male or eligible female participants
- •Physician-diagnosed CRSwNP for greater than or equals to (>=) 12 months before screening.
- •Have had at least one of the following at Visit 1:
- •Any documented history of Nasal surgery for the removal of NP (or contraindications/intolerance to Nasal surgery)
- •Have used at least 3 consecutive days of Systemic corticosteroid (SCS) or 1 intramuscular depot injectable dose (or contraindications/intolerance to SCS) in the previous 12 months (but not in the past 3 months before screening) for the treatment of NP.
- •Endoscopic bilateral NP score consistent with severe CRSwNP assessed by the investigator.
- •Symptoms of Chronic rhinosinusitis (CRS)
- •Presence of symptoms of CRS for at least 12 weeks prior to Visit 1 such as rhinorrhea and/or reduction or loss of smell and
- •Moderate to severe nasal congestion/blockade/obstruction at Visit 1 based on clinical assessment by the investigator.
- •Participants must have an elevated SNOT-22 score at screening.
- •Participants must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least the 8 weeks prior to screening.
排除标准
- •As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
- •Have the following conditions:- Cystic fibrosis, Antrochoanal polyps, Nasal cavity tumor (malignant or benign), Fungal rhinosinusitis, Rhinitis medicamentosa, Hyper-eosinophilic syndrome (HES) Eosinophilic granulomatosis with polyangiitis (EGPA) or Churg-Strauss Syndrome or eosinophilic esophagitis, Helminth parasitic infection in the past 6 months unless treated and have responded to therapy.
- •Female who are pregnant
- •Known substance or alcohol abuse
- •Current smokers (including e-cigarettes) or ex-smokers of 6 months or less
- •Other significant medical conditions (eg immunogenicity, Human immunodeficiency virus [HIV], viral hepatitis, tuberculosis [TB], cardiac and liver disease) that could impact participants' safety or study outcomes.
- •Where nasal surgery is contraindicated
- •Nasal surgery in the past 6 months
- •Asthma exacerbation in the past 4 weeks.
研究组 & 干预措施
Participants receiving GSK5784283 + standard of care (SoC)
Experimental
干预措施: Standard of Care (Drug)
Participants receiving GSK5784283 + standard of care (SoC)
Experimental
干预措施: GSK5784283 (Drug)
Participants receiving Placebo + SoC
Placebo Comparator
干预措施: Placebo (Drug)
Participants receiving Placebo + SoC
Placebo Comparator
干预措施: Standard of Care (Drug)
结局指标
主要结局
Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52
时间窗: Baseline and Week 52
The NP score evaluated by endoscopy ranges from 0 to 4 in each nostril, with higher score indicating worse status. The total endoscopic NP score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate worse status.
Change from Baseline in mean nasal obstruction score using Verbal Response Scale (VRS) from Week 51 through to Week 52
时间窗: Baseline, Weeks 51 to 52 (time - average)
Participants will be asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4- point VRS ranging from 0 to 3 with higher scores indicating worse status. The average of daily scores will be calculated, and data will be presented for Weeks 51-52.
次要结局
- Change from Baseline in mean symptoms score for loss of smell using VRS from Week 51 through to Week 52(Baseline, Weeks 51 to 52 (time - average))
- Change from Baseline in the mean CRSwNP composite symptom score (average of symptom VRS scores for nasal obstruction, rhinorrhea [runny nose], loss of smell, and mucus in throat) from Week 51 through to Week 52(Baseline, Weeks 51 to 52 (time - average))
- Change from Baseline in Lund Mackay Computed tomography (LMK CT) score at Week 52(Baseline and Week 52)
- Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) total score at Week 52(Baseline and Week 52)
- Time to first Nasal surgery decision or disease-modulating medication (DMM) or use of Systemic corticosteroid (SCS) for CRSwNP(Up to Week 52)
- Time to first Nasal surgery decision or DMM(Up to Week 52)
- Time to first use of SCS for CRSwNP(Up to Week 52)
- Change from Baseline in Asthma control questionnaire (5-item version) (ACQ-5) score at Week 52(Baseline and Week 52)
研究者
研究点 (1)
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