A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of GR1802 Injection in Combination With Background Therapy in Patients With SAR.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 15
- 主要终点
- Change from Baseline in rTNSS( reflective total nasal symptom scores)
研究概览
简要总结
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form.
- •Seasonal allergic rhinitis has been prevalent for at least 2 years.
- •Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
- •Positive SPT or serum-specific IgE test results.
- •Symptom severity scores for the season met the enrollment criteria.
排除标准
- •Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
- •Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
- •Subjects with poorly controlled recent asthma conditions.
- •Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
- •Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
- •Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.
研究组 & 干预措施
Interleukin-4 receptor responder 1
干预措施: GR1802 injection (Biological)
Interleukin-4 receptor responder 2
干预措施: GR1802 injection (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Change from Baseline in rTNSS( reflective total nasal symptom scores)
时间窗: Over 2 weeks
TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.
次要结局
- Change from Baseline in rTNSS(Over 4 weeks)
- Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(week2、4)
- Adverse events (AEs)(up to 12 weeks)
- Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(week 2、4)
- Change from Baseline in rTOSS( reflective total ocular symptom scores)(Over 2、4 weeks)
- Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(week 2、4)
- Change from baseline in VAS(Visual Analog Scale) score(week2、4)
- Immunogenicity characteristics(up to 12 weeks)