A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/LY3650150 in Participants with Chronic Rhinosinusitis with Nasal Polyps on Background Intranasal Corticosteroids
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 61
- 主要终点
- 1. Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
研究概览
简要总结
To evaluate the efficacy of lebrikizumab compared to placebo in reducing nasal congestion severity and endoscopic nasal polyp score (NPS) on background intranasal corticosteroids (INCS) at Week 24
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).
- •Prior treatment with systemic corticosteroids (SCS) for CRS or CRSwNP within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.
- •Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.
- •Ongoing symptoms for at least 8 weeks prior to study entry (screening), including: a. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and b. At least one other symptom, such as, but not limited to, partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.
- •Patients who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
排除标准
- •Have received a dose of lebrikizumab.
- •Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.
- •Allergen immunotherapy (subcutaneous immunotherapy [SCIT]/sublingual immunotherapy [SLIT]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening) or may require a dose change during study.
- •Prior or current biologic treatment for CRSwNP and/or asthma and/or atopic dermatitis (AD), including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab.
- •Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit: a. B cell-depleting biologics, including rituximab, within 6 months. b. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. c. Systemic immunosuppressants within 4 weeks prior to baseline.
- •Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening
- •Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS
- •Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline: a. Nasal septal deviation occluding at least one nostril. b. Antrochoanal polyps. c. Acute sinusitis, acute nasal infection, or acute upper respiratory infection. d. Ongoing rhinitis medicamentosa. e. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young’s syndrome, primary ciliary dyskinesia, cystic fibrosis). f. A nasal cavity tumor (malignant or benign). g. Evidence of fungal rhinosinusitis.
- •Have anosmia from COVID or any reason other than CRSwNP.
- •Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.
- •Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.
结局指标
主要结局
1. Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
1. Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary. [Time Frame: Baseline, Week 24]
NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary. [Time Frame: Baseline, Week 24]
2. Mean CFBL in Endoscopic Nasal Polyp Score (NPS) The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps. [Time Frame: Baseline, Week 24]
2. Mean CFBL in Endoscopic Nasal Polyp Score (NPS) The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps. [Time Frame: Baseline, Week 24]
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.