A Multicenter Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1802 Injection in Combination With Background Therapy in Patients With Seasonal Allergic Rhinitis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)(Part One)
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.
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)
盲法说明
Part one subjects received open-label treatment. Part two subjects received double-blind treatment.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, 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.Positive for allergens associated with seasonal allergic rhinitis.
- •Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
- •Weight≥30kg.
- •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(Part One)
Part one
干预措施: GR1802 injection (Biological)
Interleukin-4 receptor responder(Part Two)
Part two
干预措施: GR1802 injection (Biological)
Placebo
Part two
干预措施: Placebo (Biological)
结局指标
主要结局
Adverse events (AEs)(Part One)
时间窗: up to 12 weeks
Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two)
时间窗: up to 2 weeks
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
次要结局
- Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(Part One/Two)(week2、4)
- Incidence of ADAs(Part One/Two)(up to 12 weeks)
- drug concentration、Ctrough(Part One/Two)(up to 12 weeks)
- Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two)(up to 2、4 weeks)
- Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two)(week 2、4)
- Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two)(week 2、4)
- Percentage Change from Baseline in rTNSS(Part One/Two)(up to 2、4 weeks)