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Completed

NCT Number: NCT07052097

Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing TongRen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

TQC2938 injection

Drug

TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.

TQC2938 Placebo

Drug

TQC2938 placebo, 4 weeks as a treatment cycle.

Primary outcomes

  1. Retrospective nasal symptom score after 2 weeks

    Time frame: 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.

Secondary outcomes

  1. Retrospective nasal symptom score after 4 weeks

    Time frame: Baseline up to 4 weeks

    Mean daily retrospective nasal symptom total score (rTNSS) changes from baseline at 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  2. Retrospective nasal symptom score at 2-week and 4-week at day time

    Time frame: Baseline up to 2 and 4 weeks

    Mean daily changes in retrospective nasal symptom total score (AM rTNSS) from baseline at 2 weeks and 4 weeks after treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  3. Retrospective nasal symptom score at 2-week and 4-week at night time

    Time frame: Baseline up to 2 and 4 weeks

    Mean daily nightly retrospective nasal symptom total score (PM rTNSS) changes from baseline at 2 weeks and 4 weeks after treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  4. Instantaneous nasal symptom score

    Time frame: Baseline up to 2 and 4 weeks

    Mean change of instantaneous nasal symptom total score (iTNSS) from baseline every morning before treatment for 2 weeks and 4 weeks. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  5. Retrospective nasal symptom score-Mean daily rTNSS change

    Time frame: Baseline up to 2 and 4 weeks

    Mean daily rTNSS change from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  6. Peak Inspiratory Flow

    Time frame: Baseline up to 2 and 4 weeks

    Mean daily changes in peak inspiratory flow from baseline at 2 weeks and 4 weeks after treatment.

  7. Instantaneous nasal symptom score

    Time frame: Baseline up to 2 and 4 weeks

    Mean change rate of iTNSS from baseline before treatment at 2 weeks and 4 weeks each morning. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  8. Instantaneous nasal single symptom score

    Time frame: Baseline up to 2 and 4 weeks

    Mean changes from baseline in daily retrospective nasal symptom scores (runny nose, nasal congestion, nasal itchy, and sneezing) at 2 and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

  9. Instantaneous nasal single symptom score at day time

    Time frame: Baseline up to 2 and 4 weeks

    Mean changes from baseline in scores of individual nasal symptoms (runny nose, nasal congestion, itchy nose, and sneezing) were reviewed daily (AM) at 2 weeks and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

  10. Instantaneous nasal single symptom score at night time

    Time frame: Baseline up to 2 and 4 weeks

    Mean changes from baseline in scores of individual nasal symptoms (runny nose, nasal congestion, nasal itchy and sneezing) at night (PM) after 2 and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

  11. Retrospective ocular symptom score (rTOSS)

    Time frame: Baseline up to 2 and 4 weeks

    Mean changes in daily retrospective ocular symptom score (rTOSS) from baseline at 2 and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

  12. Retrospective ocular symptom score (AM rTOSS)

    Time frame: Baseline up to 2 and 4 weeks

    Mean daily changes in retrospective ocular symptom score (AM rTOSS) from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

  13. Retrospective ocular symptom score (PM rTOSS)

    Time frame: Baseline up to 2 and 4 weeks

    Mean nightly retrospective ocular symptom score (PM rTOSS) changes from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

  14. Instantaneous ocular symptom score (iTOSS)

    Time frame: Baseline up to 2 and 4 weeks

    Mean change of instantaneous ocular symptom total score (iTOSS) from baseline every morning at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

  15. Retrospective ocular symptom score ( rTOSS)

    Time frame: Baseline up to 2 and 4 weeks

    Mean rate of change in daily rTOSS from baseline at 2 and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

  16. Instantaneous ocular symptom score

    Time frame: Baseline up to 4 weeks

    Mean change rate of iTOSS from baseline before treatment at 2 weeks and 4 weeks each morning. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

  17. Retrospective ocular single symptom score

    Time frame: Baseline up to 2 and 4 weeks

    Average changes in scores of individual ocular symptoms (itchy, tearing, red eyes) at 2 and 4 weeks of treatment compared with baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

  18. Retrospective ocular single symptom score

    Time frame: Baseline up to 2 and 4 weeks

    Average changes of individual ocular symptom scores (itchy, watery eyes, red eyes) compared with baseline were reviewed daily (AM) at 2 weeks and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

  19. Retrospective ocular single symptom score

    Time frame: Baseline up to 2 and 4 weeks

    Average changes of individual ocular symptoms (itchy, watery eyes, red eyes) scores at night (PM) after 2 weeks of treatment and 4 weeks of treatment compared with baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

  20. Quality of life questionnaire

    Time frame: Baseline up to 2 and 4 weeks

    Changes in quality of life questionnaire (RQLQ) scores from baseline for patients with allergic rhinitis after 2 weeks and 4 weeks of treatment. The total score is 0-168 points, with the higher score meaning the more severe symptoms.

  21. Time of onset

    Time frame: Baseline up to 4 weeks

    Time of onset

  22. Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: Baseline up to 4 weeks

    Curative effect peak time;

  23. Area under the curve

    Time frame: Baseline up to 2 and 4 weeks

    Area under the curve of mean daily rTNSS change from baseline at 2 and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

  24. Severity of nasal symptoms (e.g., Runny nose, nasal congestion, nasal itching, and sneezing.)

    Time frame: Baseline up to 2 and 4 weeks

    2 weeks of treatment and 4 weeks of asymptomatic or mild symptoms (e.g., Runny nose, nasal congestion, nasal itching, and sneezing.).

  25. Adverse events and serious adverse events

    Time frame: Baseline up to 12 weeks

    Incidence and severity of adverse events (AE) and serious adverse events(SAE), and abnormal laboratory test indicators

  26. Blood drug concentration

    Time frame: Week 0,2, 4, 8, 12 before administration

    Blood drug concentration.

  27. Blood eosinophil (EOS) count at each evaluation visit

    Time frame: Week 0,2, 4, 8, 12 before administration

    Blood eosinophil (EOS) count and percentage at each evaluation visit.

  28. Change from baseline in serum total immunoglobulin E (IgE) concentration

    Time frame: Week 0,2, 4, 8, 12 before administration

    Change and percentage change from baseline in serum total immunoglobulin E (IgE) concentration.

  29. The incidence of antidrug antibodies (ADA)

    Time frame: Week 0,2, 4, 8, 12 before administration

    The incidence and titers of antidrug antibodies (ADA) in the test subjects. If a positive result is detected for ADA in the test subjects, then the neutralizing antibody will be tested as well.

  30. the incidence of neutralizing antibodies (Nab)

    Time frame: Week 0,2, 4, 8, 12 before administration

    The incidence of neutralizing antibodies (Nab). If a positive result is detected for ADA in the test subjects, then the neutralizing antibody will be tested as well.

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 4, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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