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Seasonal Allergic RhinitisPhase 2NCT06760182

Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis

A Phase 2 study testing TQH2722 injection in people with Seasonal Allergic Rhinitis, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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 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… 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?
TQH2722 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
169 participants
Where
30 sitesChina
Study dates
10 Mar 2025to 1 Jul 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 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;
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  • 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

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;
  • 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;
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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
  • Ansteel Group General hospital

    Anshan, Liaoning, 114000

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014000

  • 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

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061017

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia, 024005

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 015000

  • Shandong Second Provincial General Hospital

    Jinan, Shandong, 250000

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • Qilu Hospital of Shandong University

    Qilu, Shandong, 250012

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, 50000

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300041

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300192

  • Liaoning Health Industry Group Iron Coal General Hospital

    Tieling, Liaoning, 112700

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Union Hospital, Tongji Medical College, Huazhong University of science and technology

    Wuhan, Hubei, 430022

  • Tongji Hospital of Tongji medical college of HUST

    Wuhan, Hubei, 430030

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

  • Zibo Central Hospital

    Zibo, Shandong, 255036

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 TQH2722 Injection Combined With Background Therapy in Patients With Seasonal Allergic Rhinitis

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.

Being tested
TQH2722 injection, TQH2722 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.

  • TQH2722 injectionDrug

    TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).

  • TQH2722 PlaceboDrug

    Placebo without drug substance.

Study groups in NCT06760182
Study groupRoleWhat they receive
TQH2722 injectionExperimentalNot described
Receives: Drug: TQH2722 injection
TQH2722 PlaceboPlacebo comparatorTQH2722 placebo, 1 weeks as a treatment cycle.
Receives: Drug: TQH2722 Placebo

What is being measured

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

  1. Retrospective nasal symptom score after treatment for 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 (25)
  1. Retrospective nasal symptom score after treatment for 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. Mean daily changes in retrospective nasal symptom total score

    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. Mean daily nightly retrospective nasal symptom total score

    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

    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. Instantaneous nasal symptom score: Mean daily rTNSS change from baseline

    Mean daily rTNSSchange 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. Instantaneous nasal symptom score: Mean change rate of iTNSS from baseline

    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

  7. Instantaneous nasal single symptom score: Mean changes from baseline in daily retrospective nasal symptom scores

    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 single score is 0-3 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 scores of individual nasal symptoms during the day

    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 single 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: Mean changes from baseline in scores of individual nasal symptoms at night

    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 single score is 0-3 points, with the higher score meaning the more severe symptoms.

    Measured: Baseline up to 2 and 4 weeks

  10. Retrospective ocular symptom score: Mean changes in daily retrospective ocular symptom score

    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

  11. Retrospective ocular symptom score: Mean changes in retrospective ocular symptom score during the day

    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

  12. Retrospective ocular symptom score: Mean retrospective ocular symptom score at night

    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

  13. Retrospective ocular symptom score: Mean change of instantaneous ocular symptom total score

    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

  14. Retrospective ocular symptom score: Mean rate of change in daily 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

  15. Retrospective nasal symptom score: Average daily retrospective nasal symptom score

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

    Measured: Baseline up to 4 weeks

  16. Retrospective ocular symptom score: Mean change rate of iTOSS each morning

    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 2 and 4 weeks

  17. Instantaneous ocular single symptom score: Average changes in scores of individual ocular symptoms

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

    Measured: Baseline up to 2 and 4 weeks

  18. Instantaneous ocular single symptom score: Average changes of individual ocular symptom scores during the day

    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 single score is 0-3 points, with the higher score meaning the more severe symptoms.

    Measured: Baseline up to 2 and 4 weeks

  19. Instantaneous ocular single symptom score: Average changes of individual ocular symptoms at night

    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 single 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 after treatment.

    Measured: Baseline up to 4 weeks

  22. Time to Reach Maximum Plasma Concentration (Tmax)

    Time to reach maximum plasma concentration after administration.

    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

    Measured: Baseline up to 2 and 4 weeks

  24. Number of days with no or mild symptoms of Allergic rhinitis symptoms

    Number of days with no or mild symptoms during 2 weeks and 4 weeks of treatment

    Measured: Baseline up to 2 and 4 weeks

  25. Adverse event rate

    Incidence and severity of adverse events (AE) and serious adverse events (SAE), physical examination, vital signs, 12-lead electrocardiogram (ECG), and abnormal laboratory indicators.

    Measured: Baseline up to 12 weeks

Timeline

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

  1. First posted6 Jan 2025
  2. Study start10 Mar 2025
  3. Primary completion30 Apr 2025
  4. Study completion1 Jul 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
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760182
Sponsor's protocol ID
TQH2722-II-05
Status last verified
Oct 2024
First submitted
25 Dec 2024
Last updated
12 Aug 2025
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 TQH2722 injection in people with Seasonal Allergic Rhinitis, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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 11 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 12 Aug 2025. 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 treatment for 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 12 Aug 2025.

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