Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis
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
1 other identifier
interventional
136
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2025
CompletedFirst Posted
Study publicly available on registry
July 4, 2025
CompletedStudy Start
First participant enrolled
July 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2025
CompletedFebruary 10, 2026
April 1, 2025
1 month
June 8, 2025
February 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Retrospective nasal symptom score after 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.
Baseline up to 2 weeks
Secondary Outcomes (30)
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
Instantaneous nasal symptom score
Baseline up to 2 and 4 weeks
Retrospective nasal symptom score-Mean daily rTNSS change
Baseline up to 2 and 4 weeks
- +25 more secondary outcomes
Study Arms (2)
TQC2938 injection
EXPERIMENTALTQC2938 injection, 4 weeks as a treatment cycle.
TQC2938 Placebo
PLACEBO COMPARATORTQC2938 placebo, 4 weeks as a treatment cycle.
Interventions
TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing TongRen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Ganzu Province People's Hospital
Lanzhou, Ganzu, 730000, China
Cangzhou central hosipital
Cangzhou, Hebei, 061000, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050000, China
First Affiliated Hospital, Heilongjang University of Chinese Medigine
Harbin, Heilongjang, 150040, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450002, China
People'S Hospital of Zhengzhou
Zhengzhou, Henan, 450002, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450007, China
Tongji Hospital of Tongji medical college of HUST
Wuhan, Hubei, 430030, China
Baotou Central Hospital
Baotou, Inner Mongolia, 14000, China
Northern Jiangsu People'S Hospital
Yangzhou, Jiangsu, 225000, China
The first hospital of Jilin University
Changchun, Jilin, 130031, China
China-japan Friendship Hospital, Jilin University
Changchun, Jilin, 130033, China
Affiliated Zhongshan Hospital Of Dalian university
Dalian, Liaoning, 116001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xi'an, Shaanxi, 710089, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250021, China
The Second People's Hospital of Shandong Province
Jinan, Shandong, 250021, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zibo Central Hospital
Zibo, Shandong, 255020, China
First Hospital of Shangxi Medical University
Taiyuan, Shangxi, 30001, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300192, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830013, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2025
First Posted
July 4, 2025
Study Start
July 31, 2025
Primary Completion
September 12, 2025
Study Completion
November 28, 2025
Last Updated
February 10, 2026
Record last verified: 2025-04