BEACON: A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Product-related Unexpected Serious Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
详细描述
This is a Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220. The study will consist of two parts: Part 1 will enroll up to 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 40 patients. The study follow-up duration is 28 weeks.
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
- Single (Participant)
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
- •Diagnosis of chronic rhinosinusitis.
- •Has had a prior bilateral total ethmoidectomy.
- •Has computed tomography (CT) ethmoid cavity opacification.
- •Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.
- •Minimum cardinal symptom score.
- •Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.
- •Agrees to comply with all study requirements.
排除标准
- •Pregnant or breast feeding.
- •Known history of hypersensitivity or intolerance to corticosteroids.
- •History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
- •Known history of hypothalamic pituitary adrenal axial dysfunction.
- •Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- •Past or present functional vision in only one eye.
- •Past, present, or planned organ transplant or chemotherapy with immunosuppression.
- •With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
- •Ethmoidectomy that was unilateral or partial.
- •Currently participating in an investigational drug or device study.
研究组 & 干预措施
Part 1: Treatment Arm LYR-220 Design 1
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
干预措施: LYR-220 Design 1 (Part 1 only) (Drug)
Part 1 and Part 2: Treatment Arm LYR-220 Design 2
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
干预措施: LYR-220 Design 2 (Part 1 and Part 2) (Drug)
Part 2: Treatment Arm Bilateral sham procedure control
Bilateral sham procedure control
干预措施: Bilateral sham procedure control (Part 2) (Drug)
结局指标
主要结局
Product-related Unexpected Serious Adverse Events
时间窗: Through Week 28
Product-related unexpected serious adverse events
Plasma MF Concentrations
时间窗: Through Week 25
Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25. The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.
次要结局
- Adverse Events(Through Week 28)
- Endoscopic Findings(Through Week 25)
- Ophthalmic Assessment: Intraocular Pressure (IOP)(Through Week 25)
- Ophthalmic Assessment: Cataract(Through Week 25)
- Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire(Through Week 28)
- Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)(Through Week 28)