Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis
NCT ID: NCT07052097
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2025-07-31
2025-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TQC2938 injection
TQC2938 injection, 4 weeks as a treatment cycle.
TQC2938 injection
TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
TQC2938 Placebo
TQC2938 placebo, 4 weeks as a treatment cycle.
TQC2938 Placebo
TQC2938 placebo, 4 weeks as a treatment cycle.
Interventions
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TQC2938 injection
TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
TQC2938 Placebo
TQC2938 placebo, 4 weeks as a treatment cycle.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing TongRen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Ganzu Province People's Hospital
Lanzhou, Ganzu, China
Cangzhou central hosipital
Cangzhou, Hebei, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
First Affiliated Hospital, Heilongjang University of Chinese Medigine
Harbin, Heilongjang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
People'S Hospital of Zhengzhou
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji medical college of HUST
Wuhan, Hubei, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Northern Jiangsu People'S Hospital
Yangzhou, Jiangsu, China
The first hospital of Jilin University
Changchun, Jilin, China
China-japan Friendship Hospital, Jilin University
Changchun, Jilin, China
Affiliated Zhongshan Hospital Of Dalian university
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Second People's Hospital of Shandong Province
Jinan, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
First Hospital of Shangxi Medical University
Taiyuan, Shangxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
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Other Identifiers
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TQC2938-II-02
Identifier Type: -
Identifier Source: org_study_id
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