NCT07052097已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC2938 Injection Combined With Background Therapy in Patients With Seasonal Allergic Rhinitis
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.52 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年7月31日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 52
- 主要终点
- Retrospective nasal symptom score after 2 weeks
研究概览
简要总结
To evaluate TQC2938 injection in all patients receiving background treatment with azelastine fluticasone nasal spray. The efficacy, safety and immunogenicity of the injection in patients with seasonal allergic rhinitis compared with placebo are expected to include 136 patients.
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
- •Aged 18 to 75 years at the screening period
- •Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (revised edition, 2022)
- •Positive of at least 1 allergen skin prick test(SPT) and/or serum-specific IgE within 1 year before enrollment.
- •Subjects have sufficient pollen exposure during the pollen season:
- •Subjects' medical history suggested that Specific Absorption Rate (SAR) symptoms were poorly controlled or subjects' subjective symptoms were not satisfactorily controlled after drug treatment during the same pollen season in the past.
- •On the day of screening, the iTNSS score in the morning was ≥6; At baseline visit, the morning iTNSS was ≥6 points, and the average score of the past 6 rTNSS was ≥6 points;
- •During the screening/induction period, the subjects had good compliance;
- •Subjects with asthma who were assessed by the investigator or specialist as having stable asthma;
- •Voluntary participation in this trial and signing the informed consent form
- •Subjects (including partners) have no pregnancy and voluntarily take one or more non-pharmaceutical measures for contraception at period from drug administration to 6 months after the last study drug administration.
排除标准
- •Laboratory test values did not meet the requirements during screening or randomization;
- •Any disease that the investigator believes interferes with the patient's ability to complete the entire course of the study;
- •Patients with active autoimmune disease
- •People with known or suspected immunosuppression
- •Subjects with active malignancy or a history of malignancy;
- •History of active pulmonary tuberculosis within 12 months prior to screening;
- •Diagnosis of helminthic infection within 6 months prior to screening, not receiving standard treatment or not responding to standard treatment;
- •Subjects who have undergone nasal surgery or sinus surgery within 6 months before screening
- •Subjects have concomitant medical conditions that preclude them from completing the screening period assessment or evaluating the primary efficacy endpoint;
- •Subjects with nasal malignancies and benign tumors;
- •History of hypersensitivity to any content of the study drugs or its excipients
- •Subjects with a history of systemic allergy to any biological agent;
- •Pregnant or lactating women;
- •Alcohol, drug and known drug dependence;
- •Have a history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
- •Any medical or psychiatric condition that, in the investigator's judgment, puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of the study results;
- •Any condition that the investigator or primary physician believes may not be appropriate for participating the study
研究组 & 干预措施
TQC2938 injection
Experimental
TQC2938 injection, 4 weeks as a treatment cycle.
干预措施: TQC2938 injection (Drug)
TQC2938 Placebo
Placebo Comparator
TQC2938 placebo, 4 weeks as a treatment cycle.
干预措施: TQC2938 Placebo (Drug)
结局指标
主要结局
Retrospective nasal symptom score after 2 weeks
时间窗: Baseline up to 2 weeks
Average daily retrospective nasal symptom score (rTNSS) changed from baseline after 2 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
次要结局
- Retrospective nasal symptom score after 4 weeks(Baseline up to 4 weeks)
- Retrospective nasal symptom score at 2-week and 4-week at day time(Baseline up to 2 and 4 weeks)
- Retrospective nasal symptom score at 2-week and 4-week at night time(Baseline up to 2 and 4 weeks)
- Retrospective nasal symptom score-Mean daily rTNSS change(Baseline up to 2 and 4 weeks)
- Peak Inspiratory Flow(Baseline up to 2 and 4 weeks)
- Instantaneous nasal single symptom score(Baseline up to 2 and 4 weeks)
- Instantaneous nasal single symptom score at day time(Baseline up to 2 and 4 weeks)
- Instantaneous nasal single symptom score at night time(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score (rTOSS)(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score (AM rTOSS)(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score (PM rTOSS)(Baseline up to 2 and 4 weeks)
- Instantaneous ocular symptom score (iTOSS)(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score ( rTOSS)(Baseline up to 2 and 4 weeks)
- Instantaneous ocular symptom score(Baseline up to 4 weeks)
- Retrospective ocular single symptom score(Baseline up to 2 and 4 weeks)
- Quality of life questionnaire(Baseline up to 2 and 4 weeks)
- Time of onset(Baseline up to 4 weeks)
- Time to Reach Maximum Plasma Concentration (Tmax)(Baseline up to 4 weeks)
- Area under the curve(Baseline up to 2 and 4 weeks)
- Severity of nasal symptoms (e.g., Runny nose, nasal congestion, nasal itching, and sneezing.)(Baseline up to 2 and 4 weeks)
- Adverse events and serious adverse events(Baseline up to 12 weeks)
- Blood drug concentration(Week 0,2, 4, 8, 12 before administration)
- Blood eosinophil (EOS) count at each evaluation visit(Week 0,2, 4, 8, 12 before administration)
- Change from baseline in serum total immunoglobulin E (IgE) concentration(Week 0,2, 4, 8, 12 before administration)
- The incidence of antidrug antibodies (ADA)(Week 0,2, 4, 8, 12 before administration)
- the incidence of neutralizing antibodies (Nab)(Week 0,2, 4, 8, 12 before administration)
- Instantaneous nasal symptom score(Baseline up to 2 and 4 weeks)
研究者
研究点 (52)
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