NCT07398859尚未招募2 期
A Multi-center, Open-label, Phase II, Single-arm Clinical Study Evaluating the Safety and Efficacy of TQH2722 Injection Combined With Background Treatment in Subjects With Seasonal Allergic Rhinitis
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.30 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 30
- 主要终点
- Number of subjects with incidence of adverse event
研究概览
简要总结
This study is a multicenter, open-label, Phase II, single-arm clinical trial, with a planned enrollment of 200 to 300 subjects. Its primary objective is to evaluate the safety and efficacy of TQH2722 injection in the treatment of seasonal allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 18-75, with no gender restrictions.
- •Diagnosed with seasonal allergic rhinitis.
- •Positive allergen test result.
- •The subjects have sufficient exposure to pollen during the pollen season.
- •The subject's medical history indicates that the subject had poor control of Seasonal Allergic Rhinitis (SAR) symptoms during the previous pollen season or the subject was dissatisfied with the subjective symptom control.
- •Screen for subjects who have a morning iTNSS score of ≥4 on the day of screening; at baseline visit, have a morning iTNSS score of ≥4, and have an average rTNSS score of ≥4 over the past 6 days.
- •Good compliance during screening/induction period.
- •Subjects with comorbid asthma should have stable medication use before the screening period and have their asthma condition assessed as stable by the investigator or specialist.
- •The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance.
- •The subjects and their partners agree to take effective contraceptive measures throughout the entire study period (from the signing of the Informed Consent Form (ICF) to 3 months after the last administration of the trial drug).
排除标准
- •Any abnormal laboratory test value during the screening period or randomization.
- •Any disease that researchers consider to be unstable and may affect the patient's safety throughout the entire study period, or affect the study results or their interpretation, or hinder the patient's ability to complete the entire study process.
- •Patients with active autoimmune diseases.
- •Known or suspected immunosuppressants.
- •Subjects with active malignant tumors or a history of malignant tumors.
- •Screen for individuals with a history of active tuberculosis within the previous 12 months.
- •During the screening period, there is active hepatitis, or the presence of human immunodeficiency virus antibody (Anti-HIV) positivity, or syphilis treponema antibody (Anti-TP) positivity.
- •Screen for cases diagnosed with helminthic parasitic infections within the previous 6 months, who have not undergone standard treatment or have experienced ineffective standard treatment.
- •Subjects who have received specific medications or undergone any nasal or sinus surgery within the specified timeframe.
- •Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 days before screening.
- •Screen subjects who have used monoamine oxidase inhibitors within the previous 14 days.
- •Initiate allergen immunotherapy within 3 months prior to screening.
- •Screen for individuals who have received attenuated live vaccines within the previous 4 weeks or plan to receive attenuated live vaccines during the study period.
- •Screen for systemic Chinese herbal preparations used for the treatment of AR with short- or medium-acting systemic glucocorticoids within 4 weeks, or screen for long-acting Systemic Corticosteroids (SCS) received within the previous 6 weeks.
- •Suffering from chronic active or acute infection within 2 weeks before screening or during the screening and import period.
- •Patients with concomitant asthma should be excluded if they meet any of the following conditions: a. forced expiratory volume in one second (FEV1) ≤ 50% of the predicted normal value; b. acute exacerbation of asthma within 90 days prior to screening; c. currently using fluticasone propionate at a daily dose of >1000 μg/day or equivalent doses of other inhaled corticosteroids; d. assessed by the investigator or specialist as having unstable asthma.
- •The subject has a concomitant disease that renders them unable to complete the screening period assessment or evaluate the primary efficacy endpoint.
- •Suffering from malignant and benign tumors in the nasal cavity.
- •Subjects with perennial allergic rhinitis (PAR) who are allergic to pet hair.
- •Unable to use nasal corticosteroid sprays or antihistamines.
- •Have a history of systemic allergy to any biological agents.
- •Women who are pregnant or breastfeeding.
- •Individuals who abuse alcohol, use drugs, and have known drug dependency.
- •History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- •According to the researcher's judgment, there are any medical or psychiatric symptoms that may put the subjects at risk, interfere with their participation in the study, or interfere with the interpretation of the study results.
- •The forced expiratory volume in one second (FEV1) of the subject is less than or equal to 50% of the predicted normal value.
- •Other reasons why the researcher believes it is inappropriate to participate in this trial.
研究组 & 干预措施
TQH2722 injection
Experimental
Injection combined with TQH2722, 2 weeks as a treatment cycle.
干预措施: TQH2722 injection (Drug)
结局指标
主要结局
Number of subjects with incidence of adverse event
时间窗: Baseline up to 4 weeks
Adverse events occurring during treatment.
次要结局
- Number of subjects with incidence of serious adverse event(Baseline up to 4 weeks)
- Number of subjects with incidence of abnormality check indicators(Baseline up to 4 weeks)
- Retrospective nasal symptom score after treatment for 2 weeks(Baseline up to 2 weeks)
- Retrospective nasal symptom score after treatment for 4 weeks(Baseline up to 4 weeks)
- Mean daily morning retrospective total nasal symptom score(Baseline up to 2 and 4 weeks)
- Mean daily retrospective total nasal symptom score at night(Baseline up to 2 and 4 weeks)
- Total instantaneous nasal symptom score before medication in the morning every day(Baseline up to 2 and 4 weeks)
- Daily retrospective total nasal symptom score(Baseline up to 2 and 4 weeks)
- Daily retrospective scoring of individual nasal symptoms(Baseline up to 2 and 4 weeks)
- Daily retrospective nasal single symptom score during daytime(Baseline up to 2 and 4 weeks)
- Daily retrospective nasal single symptom score during night(Baseline up to 2 and 4 weeks)
- Daily retrospective total score of ocular symptoms(Baseline up to 2 and 4 weeks)
- Total score of retrospective ocular symptoms during daytime each day(Baseline up to 2 and 4 weeks)
- Total score of retrospective ocular symptoms each night(Baseline up to 2 and 4 weeks)
- Total score of instantaneous ocular symptoms before medication in the morning every day(Baseline up to 2 and 4 weeks)
- Total score of instantaneous ocular symptoms before medication each morning(Baseline up to 2 and 4 weeks)
- Daily retrospective scoring of individual ocular symptoms(Baseline up to 2 and 4 weeks)
- Daily retrospective scoring of individual ocular symptoms during the day(Baseline up to 2 and 4 weeks)
- Nightly retrospective scoring of individual ocular symptoms(Baseline up to 2 and 4 weeks)
- Quality of Life Questionnaire Score for Patients with Allergic Rhinitis(Baseline up to 2 and 4 weeks)
- Daily retrospective total score of nasal symptoms(Baseline up to 2 and 4 weeks)
- Blood eosinophil count and percentage(Baseline up 12 weeks)
- Serum total immunoglobulin E concentration(Baseline up 12 weeks)
- Forced expiratory volume in 1 second (FEV1) before bronchodilator administration (BD) in subjects with concomitant asthma(Baseline up 12 week)
研究者
研究点 (30)
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