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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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