ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.
研究概览
简要总结
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
详细描述
This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosed as having CRS
- •Undergone at least 2 trials of medical treatments in the past
- •Mean 3 cardinal symptom (3CS) score
- •Bilateral ethmoid disease confirmed on CT
- •Has been informed of the nature of the study and provided written informed consent
- •Agrees to comply with all study requirements
- •If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study.
排除标准
- •Inability to tolerate topical anesthesia or endoscopic procedure
- •Previous nasal surgery
- •Presence of nasal polyp grade 2 or higher
- •Seasonal allergic rhinitis
- •Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
- •Severe asthma
- •History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
- •Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
- •Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
- •Known history of hypersensitivity or intolerance to corticosteroids
- •Known history of hypothalamic pituitary adrenal axial dysfunction
- •Previous pituitary or adrenal surgery
- •Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- •Past or present acute or chronic intracranial or orbital complications of CRS
- •History or diagnosis (in either eye) of glaucoma or ocular hypertension
- •Past or present functional vision in only 1 eye
- •Past, present, or planned organ transplant or chemotherapy with immunosuppression
- •Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
- •Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
- •Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
- •Currently participating in an investigational drug or device study
- •Determined by the investigator as not suitable to be enrolled
研究组 & 干预措施
LYR-210
Single administration of LYR-210 drug matrix (7500 μg)
干预措施: LYR-210 (Drug)
LYR-210
Single administration of LYR-210 drug matrix (7500 μg)
干预措施: Background Therapy (Other)
Sham procedure control
Single mock administration procedure
干预措施: Sham procedure control (Drug)
Sham procedure control
Single mock administration procedure
干预措施: Background Therapy (Other)
结局指标
主要结局
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.
时间窗: 24 Weeks
The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
次要结局
- CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.(Week 24)
- CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24(Week 24)
- CFBL in the 3-D Volumetric CT Score at Week 20(Week 20)
- Participants With Rescue Treatments for CRS Through Week 24(Week 24)