Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis

March 26, 2026 updated by: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

A Multi-center, Open-label, Phase II, Single-arm Clinical Study Evaluating the Safety and Efficacy of TQH2722 Injection Combined With Background Treatment in Subjects With Seasonal Allergic Rhinitis

This study is a multicenter, open-label, Phase II, single-arm clinical trial, with a planned enrollment of 200 to 300 subjects. Its primary objective is to evaluate the safety and efficacy of TQH2722 injection in the treatment of seasonal allergic rhinitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100034
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100044
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Yucheng Yang, Doctor
          • Phone Number: 13452018123
          • Email: yychxh@163.com
    • Hebei
      • Baoding, Hebei, China, 071000
        • Not yet recruiting
        • Hebei University Affiliated Hospital
        • Contact:
          • Congzhe Tian, Master
          • Phone Number: 13230238686
          • Email: enttcz@163.com
      • Cangzhou, Hebei, China, 061017
        • Not yet recruiting
        • Cangzhou Central Hospital
        • Contact:
      • Langfang, Hebei, China, 65000
        • Not yet recruiting
        • Hebei PetroChina Central Hospital
        • Contact:
      • Shijiazhuang, Hebei, China, 50000
        • Not yet recruiting
        • Hebei medical university third hospital
        • Contact:
      • Shijiazhuang, Hebei, China, 050051
        • Not yet recruiting
        • Hebei Provincial People's Hospital
        • Contact:
      • Zhangjiakou, Hebei, China, 075000
        • Not yet recruiting
        • The First Affiliated Hospital of Hebei North University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430014
        • Not yet recruiting
        • The Central Hospital of Wuhan
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital of Tongji Medical College of HUST
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 716000
        • Not yet recruiting
        • Yan'an University Xianyang Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Shandong Second Provincial General Hospital
        • Contact:
      • Yantai, Shandong, China, 264000
        • Not yet recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
      • Zibo, Shandong, China, 255036
        • Not yet recruiting
        • Zibo Central Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • Hospital of Chengdu University of Traditional Chinese Medicine
        • Contact:
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • Second People's Hospital of Chengdu
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300121
        • Not yet recruiting
        • Tianjin People's Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Not yet recruiting
        • The first affiliated hospital of Xinjiang medical university
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Not yet recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
      • Kunming, Yunnan, China, 650032
        • Not yet recruiting
        • Yunnan Provincial Hospital of Chinese Medicine
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-75, with no gender restrictions.
  • Diagnosed with seasonal allergic rhinitis.
  • Positive allergen test result.
  • The subjects have sufficient exposure to pollen during the pollen season.
  • The subject's medical history indicates that the subject had poor control of Seasonal Allergic Rhinitis (SAR) symptoms during the previous pollen season or the subject was dissatisfied with the subjective symptom control.
  • Screen for subjects who have a morning iTNSS score of ≥4 on the day of screening; at baseline visit, have a morning iTNSS score of ≥4, and have an average rTNSS score of ≥4 over the past 6 days.
  • Good compliance during screening/induction period.
  • Subjects with comorbid asthma should have stable medication use before the screening period and have their asthma condition assessed as stable by the investigator or specialist.
  • The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance.
  • The subjects and their partners agree to take effective contraceptive measures throughout the entire study period (from the signing of the Informed Consent Form (ICF) to 3 months after the last administration of the trial drug).

Exclusion Criteria:

  • Any abnormal laboratory test value during the screening period or randomization.
  • Any disease that researchers consider to be unstable and may affect the patient's safety throughout the entire study period, or affect the study results or their interpretation, or hinder the patient's ability to complete the entire study process.
  • Patients with active autoimmune diseases.
  • Known or suspected immunosuppressants.
  • Subjects with active malignant tumors or a history of malignant tumors.
  • Screen for individuals with a history of active tuberculosis within the previous 12 months.
  • During the screening period, there is active hepatitis, or the presence of human immunodeficiency virus antibody (Anti-HIV) positivity, or syphilis treponema antibody (Anti-TP) positivity.
  • Screen for cases diagnosed with helminthic parasitic infections within the previous 6 months, who have not undergone standard treatment or have experienced ineffective standard treatment.
  • Subjects who have received specific medications or undergone any nasal or sinus surgery within the specified timeframe.
  • Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 days before screening.
  • Screen subjects who have used monoamine oxidase inhibitors within the previous 14 days.
  • Initiate allergen immunotherapy within 3 months prior to screening.
  • Screen for individuals who have received attenuated live vaccines within the previous 4 weeks or plan to receive attenuated live vaccines during the study period.
  • Screen for systemic Chinese herbal preparations used for the treatment of AR with short- or medium-acting systemic glucocorticoids within 4 weeks, or screen for long-acting Systemic Corticosteroids (SCS) received within the previous 6 weeks.
  • Suffering from chronic active or acute infection within 2 weeks before screening or during the screening and import period.
  • Patients with concomitant asthma should be excluded if they meet any of the following conditions: a. forced expiratory volume in one second (FEV1) ≤ 50% of the predicted normal value; b. acute exacerbation of asthma within 90 days prior to screening; c. currently using fluticasone propionate at a daily dose of >1000 μg/day or equivalent doses of other inhaled corticosteroids; d. assessed by the investigator or specialist as having unstable asthma.
  • The subject has a concomitant disease that renders them unable to complete the screening period assessment or evaluate the primary efficacy endpoint.
  • Suffering from malignant and benign tumors in the nasal cavity.
  • Subjects with perennial allergic rhinitis (PAR) who are allergic to pet hair.
  • Unable to use nasal corticosteroid sprays or antihistamines.
  • Have a history of systemic allergy to any biological agents.
  • Women who are pregnant or breastfeeding.
  • Individuals who abuse alcohol, use drugs, and have known drug dependency.
  • History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
  • According to the researcher's judgment, there are any medical or psychiatric symptoms that may put the subjects at risk, interfere with their participation in the study, or interfere with the interpretation of the study results.
  • The forced expiratory volume in one second (FEV1) of the subject is less than or equal to 50% of the predicted normal value.
  • Other reasons why the researcher believes it is inappropriate to participate in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQH2722 injection
Injection combined with TQH2722, 2 weeks as a treatment cycle.
Drug: TQH2722 injection
TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with incidence of adverse event
Time Frame: Baseline up to 4 weeks
Adverse events occurring during treatment.
Baseline up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with incidence of serious adverse event
Time Frame: Baseline up to 4 weeks
Serious adverse event occurring during treatment.
Baseline up to 4 weeks
Number of subjects with incidence of abnormality check indicators
Time Frame: Baseline up to 4 weeks
Number of subjects with incidence of abnormality check indicators: Abnormal examination indicators occurred during treatment.
Baseline up to 4 weeks
Retrospective nasal symptom score after treatment for 2 weeks
Time Frame: Baseline up to 2 weeks
The average change in the retrospective total nasal symptom score (rTNSS) per day over 2 weeks of treatment compared to baseline. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Baseline up to 2 weeks
Retrospective nasal symptom score after treatment for 4 weeks
Time Frame: Baseline up to 4 weeks
The average change in the retrospective total nasal symptom score (rTNSS) per day over 4 weeks of treatment compared to baseline. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Baseline up to 4 weeks
Mean daily morning retrospective total nasal symptom score
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in the morning retrospective total nasal symptom score (AM rTNSS) at 2 weeks and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Baseline up to 2 and 4 weeks
Mean daily retrospective total nasal symptom score at night
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in the Post-Medication Reviewed Total Nasal Symptom Score (PMrTNSS) at night per day at 2 weeks and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Baseline up to 2 and 4 weeks
Total instantaneous nasal symptom score before medication in the morning every day
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in instantaneous total nasal symptom score (iTNSS) before medication administration in the morning, for each day during the 2-week and 4-week treatment periods. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Baseline up to 2 and 4 weeks
Daily retrospective total nasal symptom score
Time Frame: Baseline up to 2 and 4 weeks
Mean percentage change from baseline in daily rTNSS at 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Total instantaneous nasal symptom score before medication in the morning every day
Time Frame: Baseline up to 2 and 4 weeks
Mean percentage change from baseline in iTNSS before medication administration in the morning, for each day during the 2-week and 4-week treatment periods.
Baseline up to 2 and 4 weeks
Daily retrospective scoring of individual nasal symptoms
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in daily retrospective nasal single symptom scores at 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Daily retrospective nasal single symptom score during daytime
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in retrospective daytime (AM) nasal individual symptom scores (rhinorrhea, nasal congestion, nasal itch, and sneezing) at 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Daily retrospective nasal single symptom score during night
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in retrospective nasal individual symptom (rhinorrhea, nasal congestion, nasal itch, and sneezing) scores at night (PM) at 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Daily retrospective total score of ocular symptoms
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in the retrospective Total Ocular Symptom Score (rTOSS) at 2 weeks or 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Total score of retrospective ocular symptoms during daytime each day
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in the total daytime retrospective ocular symptom score (AM rTOSS) at 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Total score of retrospective ocular symptoms each night
Time Frame: Baseline up to 2 and 4 weeks
The average change in the retrospective total ocular symptom score (PM rTOSS) at night compared to baseline after 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Total score of instantaneous ocular symptoms before medication in the morning every day
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in instantaneous total ocular symptom score (iTOSS) before medication administration in the morning, at 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Daily retrospective total score of ocular symptoms
Time Frame: Baseline up to 2 and 4 weeks
Mean percentage change in total retrospective ocular symptom score from baseline at 2 weeks and 4 weeks of treatment, respectively.
Baseline up to 2 and 4 weeks
Total score of instantaneous ocular symptoms before medication each morning
Time Frame: Baseline up to 2 and 4 weeks
Mean percentage change from baseline in total ocular symptom score immediately before medication administration in the morning, for the 2-week and 4-week treatment periods.
Baseline up to 2 and 4 weeks
Daily retrospective scoring of individual ocular symptoms
Time Frame: Baseline up to 2 and 4 weeks
Mean change in individual ocular symptom scores from baseline to 2 weeks and 4 weeks after treatment, retrospectively assessed daily.
Baseline up to 2 and 4 weeks
Daily retrospective scoring of individual ocular symptoms during the day
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in retrospective ocular symptom scores during daytime (AM) on each day at 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Nightly retrospective scoring of individual ocular symptoms
Time Frame: Baseline up to 2 and 4 weeks
Mean change from baseline in retrospective ocular symptom scores at night (PM) at 2 weeks and 4 weeks of treatment
Baseline up to 2 and 4 weeks
Quality of Life Questionnaire Score for Patients with Allergic Rhinitis
Time Frame: Baseline up to 2 and 4 weeks
The change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores from baseline for patients with allergic rhinitis after 2 weeks and 4 weeks of treatment.
Baseline up to 2 and 4 weeks
Daily retrospective total score of nasal symptoms
Time Frame: Baseline up to 2 and 4 weeks
The area under the curve representing the average change in the retrospective total nasal symptom score (rTNSS) from baseline, calculated for each day during the 2-week and 4-week treatment periods.
Baseline up to 2 and 4 weeks
Blood eosinophil count and percentage
Time Frame: Baseline up 12 weeks
Changes in eosinophil count and percentage from baseline, as well as the percentage of change, at each evaluation visit point.
Baseline up 12 weeks
Serum total immunoglobulin E concentration
Time Frame: Baseline up 12 weeks
The changes in serum total immunoglobulin E concentration and the percentage of change from baseline at each evaluation visit point.
Baseline up 12 weeks
Forced expiratory volume in 1 second (FEV1) before bronchodilator administration (BD) in subjects with concomitant asthma
Time Frame: Baseline up 12 week
The change in forced expiratory volume in one second (FEV1) relative to baseline before the use of bronchodilator (BD) in subjects with asthma across all visit points.
Baseline up 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQH2722-II-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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