NCT06760182已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH2722 Injection Combined With Background Therapy in Patients 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 169 人开始时间: 2025年3月10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
- 169
- 试验地点
- 30
- 主要终点
- Retrospective nasal symptom score after treatment for 2 weeks
研究概览
简要总结
To evaluate TQH2722 injection in all patients receiving background treatment with mometasone furoate nasal spray (MFNS) and loratadine. The efficacy, safety and immunogenicity of the solution in patients with seasonal allergic rhinitis compared with placebo are expected to include 168 patients with confirmed seasonal allergic rhinitis (SAR) who have failed to respond to standard treatments.
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 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 ≥4; At baseline visit, the morning iTNSS was ≥4 points, and the average score of the past 6 rTNSS was ≥6 points;
- •At baseline visit, the absolute value of peripheral blood eosinophils was ≥0.15×109/L;
- •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;
- •Active hepatitis or hepatitis B was present during the screening period; Or human immunodeficiency virus antibody (Anti-HIV) positive, or treponema pallidum antibody (Anti-TP) positive;
- •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
TQH2722 injection
Experimental
干预措施: TQH2722 injection (Drug)
TQH2722 Placebo
Placebo Comparator
TQH2722 placebo, 1 weeks as a treatment cycle.
干预措施: TQH2722 Placebo (Drug)
结局指标
主要结局
Retrospective nasal symptom score after treatment for 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 ocular symptom score: Mean changes in daily retrospective ocular symptom score(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score: Mean changes in retrospective ocular symptom score during the day(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score: Mean retrospective ocular symptom score at night(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score: Mean change of instantaneous ocular symptom total score(Baseline up to 2 and 4 weeks)
- Retrospective ocular symptom score: Mean rate of change in daily rTOSS(Baseline up to 2 and 4 weeks)
- Retrospective nasal symptom score: Average daily retrospective nasal symptom score(Baseline up to 4 weeks)
- Retrospective ocular symptom score: Mean change rate of iTOSS each morning(Baseline up to 2 and 4 weeks)
- Instantaneous ocular single symptom score: Average changes in scores of individual ocular symptoms(Baseline up to 2 and 4 weeks)
- Instantaneous ocular single symptom score: Average changes of individual ocular symptom scores during the day(Baseline up to 2 and 4 weeks)
- Instantaneous ocular single symptom score: Average changes of individual ocular symptoms at night(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)
- Number of days with no or mild symptoms of Allergic rhinitis symptoms(Baseline up to 2 and 4 weeks)
- Adverse event rate(Baseline up to 12 weeks)
- Retrospective nasal symptom score after treatment for 4 weeks(Baseline up to 4 weeks)
- Mean daily changes in retrospective nasal symptom total score(Baseline up to 2 and 4 weeks)
- Mean daily nightly retrospective nasal symptom total score(Baseline up to 2 and 4 weeks)
- Instantaneous nasal symptom score: Mean change of instantaneous nasal symptom total score (iTNSS) from baseline(Baseline up to 2 and 4 weeks)
- Instantaneous nasal symptom score: Mean daily rTNSS change from baseline(Baseline up to 2 and 4 weeks)
- Instantaneous nasal symptom score: Mean change rate of iTNSS from baseline(Baseline up to 2 and 4 weeks)
- Instantaneous nasal single symptom score: Mean changes from baseline in daily retrospective nasal symptom scores(Baseline up to 2 and 4 weeks)
- Instantaneous nasal single symptom score: Mean changes from baseline in scores of individual nasal symptoms during the day(Baseline up to 2 and 4 weeks)
- Instantaneous nasal single symptom score: Mean changes from baseline in scores of individual nasal symptoms at night(Baseline up to 2 and 4 weeks)
研究者
研究点 (30)
Loading locations...
相似试验
已完成
2 期
A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.SinusitisNCT06089278Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.160
已完成
2 期
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent AsthmaAsthmaNCT01555151Novartis Pharmaceuticals739
Unknown
1 期
A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult SubjectsAtopic DermatitisNCT05409326Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.48
已完成
3 期
Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)Adenoids HypertrophyNCT00552032Organon and Co132
已完成
2 期
A Study of ATH-1017 in Mild to Moderate Alzheimer's DiseaseAlzheimer DiseaseDementia of Alzheimer TypeNCT04491006Athira Pharma77