A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/ LY3650150 in Adult Participants With Perennial Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 129
- 主要终点
- Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis.
Participants can expect study participation to last up to 29.5 months.
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, Investigator)
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
- •Physician-diagnosed perennial allergic rhinitis (PAR).
- •Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
- •The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test.
- •A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
- •Participants 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.
- •Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.
- •Have received treatment with any rescue medication during the run-in period.
- •Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:
- •Any current or prior use of biologics indicated for asthma or AD are prohibited.
- •B cell-depleting biologics, including rituximab, within 6 months.
- •Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- •Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline.
- •Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period.
- •Anticipates significant changes in their daily environmental exposure.
- •Has a known history of recurrent acute or chronic sinusitis.
- •Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
研究组 & 干预措施
Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
干预措施: Standard therapy for INCS (Drug)
Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
干预措施: Standard therapy for INCS (Drug)
Placebo Q2W/Q4W
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
干预措施: Placebo (Drug)
Placebo Q2W/Q4W
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
干预措施: Standard therapy for INCS (Drug)
Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
干预措施: LY3650150 (Drug)
Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
干预措施: LY3650150 (Drug)
结局指标
主要结局
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
时间窗: Baseline, Week 16
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
次要结局
- Mean CFBL in RQLQ(S) Total Score at Week 56(Baseline, Week 56)
- Mean CFBL in TNSS at Week 4(Baseline, Week 4)
- Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16(Baseline, Week 16)
- Mean CFBL in RQLQ(S) Activities Domain at Week 56(Baseline, Week 56)
- Mean CFBL in RQLQ(S) Total Score at Week 16(Baseline, Week 16)
- Mean CFBL in RQLQ(S) Total Score at Week 56(Baseline, Week 56)
- Mean CFBL in TNSS at Week 56(Baseline, Week 56)
- Mean CFBL in Postnasal Drip Score at Week 16(Baseline, Week 16)