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Seasonal Allergic RhinitisPhase 2NCT07052097

Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis

A Phase 2 study testing TQC2938 injection in people with Seasonal Allergic Rhinitis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Seasonal Allergic Rhinitis
What is being tested?
TQC2938 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
30 sitesChina
Study dates
31 Jul 2025to 28 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites
  • Baotou Central Hospital

    Baotou, Inner Mongolia, 14000

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing TongRen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Cangzhou central hosipital

    Cangzhou, Hebei, 061000

  • The first hospital of Jilin University

    Changchun, Jilin, 130031

  • China-japan Friendship Hospital, Jilin University

    Changchun, Jilin, 130033

  • Affiliated Zhongshan Hospital Of Dalian university

    Dalian, Liaoning, 116001

  • First Affiliated Hospital, Heilongjang University of Chinese Medigine

    Harbin, Heilongjang, 150040

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250021

  • The Second People's Hospital of Shandong Province

    Jinan, Shandong, 250021

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Ganzu Province People's Hospital

    Lanzhou, Ganzu, 730000

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, 050000

  • First Hospital of Shangxi Medical University

    Taiyuan, Shangxi, 30001

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300192

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830013

  • Tongji Hospital of Tongji medical college of HUST

    Wuhan, Hubei, 430030

  • Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

    Xi'an, Shaanxi, 710089

  • Northern Jiangsu People'S Hospital

    Yangzhou, Jiangsu, 225000

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450002

  • People'S Hospital of Zhengzhou

    Zhengzhou, Henan, 450002

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450007

  • Zibo Central Hospital

    Zibo, Shandong, 255020

Other trials in China

About this study

Official 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

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.

Being tested
TQC2938 injection, TQC2938 Placebo
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQC2938 injectionDrug

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

  • TQC2938 PlaceboDrug

    TQC2938 placebo, 4 weeks as a treatment cycle.

Study groups in NCT07052097
Study groupRoleWhat they receive
TQC2938 injectionExperimentalTQC2938 injection, 4 weeks as a treatment cycle.
Receives: Drug: TQC2938 injection
TQC2938 PlaceboPlacebo comparatorTQC2938 placebo, 4 weeks as a treatment cycle.
Receives: Drug: TQC2938 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to 2 weeks

Secondary outcomes (30)
  1. Retrospective nasal symptom score after 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.

    Measured: Baseline up to 4 weeks

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

    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.

    Measured: Baseline up to 2 and 4 weeks

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

    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.

    Measured: Baseline up to 2 and 4 weeks

  4. Instantaneous nasal symptom score

    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.

    Measured: Baseline up to 2 and 4 weeks

  5. Retrospective nasal symptom score-Mean daily rTNSS change

    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.

    Measured: Baseline up to 2 and 4 weeks

  6. Peak Inspiratory Flow

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

    Measured: Baseline up to 2 and 4 weeks

  7. Instantaneous nasal symptom score

    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.

    Measured: Baseline up to 2 and 4 weeks

  8. Instantaneous nasal single symptom score

    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.

    Measured: Baseline up to 2 and 4 weeks

  9. Instantaneous nasal single symptom score at day time

    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.

    Measured: Baseline up to 2 and 4 weeks

  10. Instantaneous nasal single symptom score at night time

    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.

    Measured: Baseline up to 2 and 4 weeks

  11. Retrospective ocular symptom score (rTOSS)

    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.

    Measured: Baseline up to 2 and 4 weeks

  12. Retrospective ocular symptom score (AM rTOSS)

    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.

    Measured: Baseline up to 2 and 4 weeks

  13. Retrospective ocular symptom score (PM rTOSS)

    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.

    Measured: Baseline up to 2 and 4 weeks

  14. Instantaneous ocular symptom score (iTOSS)

    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.

    Measured: Baseline up to 2 and 4 weeks

  15. Retrospective ocular symptom score ( rTOSS)

    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.

    Measured: Baseline up to 2 and 4 weeks

  16. Instantaneous ocular symptom score

    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.

    Measured: Baseline up to 4 weeks

  17. Retrospective ocular single symptom score

    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.

    Measured: Baseline up to 2 and 4 weeks

  18. Retrospective ocular single symptom score

    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.

    Measured: Baseline up to 2 and 4 weeks

  19. Retrospective ocular single symptom score

    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.

    Measured: Baseline up to 2 and 4 weeks

  20. Quality of life questionnaire

    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.

    Measured: Baseline up to 2 and 4 weeks

  21. Time of onset

    Time of onset

    Measured: Baseline up to 4 weeks

  22. Time to Reach Maximum Plasma Concentration (Tmax)

    Curative effect peak time;

    Measured: Baseline up to 4 weeks

  23. Area under the curve

    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.

    Measured: Baseline up to 2 and 4 weeks

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

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

    Measured: Baseline up to 2 and 4 weeks

  25. Adverse events and serious adverse events

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

    Measured: Baseline up to 12 weeks

  26. Blood drug concentration

    Blood drug concentration.

    Measured: Week 0,2, 4, 8, 12 before administration

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

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

    Measured: Week 0,2, 4, 8, 12 before administration

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

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

    Measured: Week 0,2, 4, 8, 12 before administration

  29. The incidence of antidrug antibodies (ADA)

    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.

    Measured: Week 0,2, 4, 8, 12 before administration

  30. the incidence of neutralizing antibodies (Nab)

    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.

    Measured: Week 0,2, 4, 8, 12 before administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start31 Jul 2025
  3. Primary completion12 Sep 2025
  4. Study completion28 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052097
Sponsor's protocol ID
TQC2938-II-02
Status last verified
Apr 2025
First submitted
8 Jun 2025
Last updated
10 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQC2938 injection in people with Seasonal Allergic Rhinitis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retrospective nasal symptom score after 2 weeks (time frame: Baseline up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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