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Seasonal Allergic RhinitisPhase 2NCT07398859

Clinical Study on TQH2722 Injection Combined With Background Therapy for 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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. 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?
No, everyone receives an active treatment
How many people
300 participants
Where
30 sitesChina
Study dates
19 Mar 2026to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18-75, 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.
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zheng Liu, Doctor contact

18607110505

zhengliuent@hotmail.com

Rongfei Zhu, Doctor contact

18986292602

zrf13092@163.com

30 sites in 1 country

China30 sites, 30 recruiting
  • Hebei University Affiliated Hospital

    Baoding, Hebei, 071000

    Congzhe Tian, Master, 13230238686, enttcz@163.com

    Not yet recruiting
  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Junxiu Liu, Doctor, 13439607635, liujunxiusanyuan@sina.com

    Not yet recruiting
  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Zhimin Xing, Master, 13681596878, xingzhimin27@163.com

    Not yet recruiting
  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Yan Yan, Doctor, 15611908358, wzyyer34@163.com

    Recruiting
  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061017

    Weiwei Liu, Master, 13393275339, lwwczbj@163.com

    Not yet recruiting
  • Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610000

    Yan Xie, Master, 15008228100, xieyan000.@163.com

    Not yet recruiting
  • Second People's Hospital of Chengdu

    Chengdu, Sichuan, 610000

    Jia Chen, Master, 13980805288, 904297144@qq.com

    Not yet recruiting
  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    Yucheng Yang, Doctor, 13452018123, yychxh@163.com

    Recruiting
  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Weiming Hu, Doctor, 13588426686, Huwm93@163.com

    Not yet recruiting
  • Shandong Second Provincial General Hospital

    Jinan, Shandong, 250000

    Li Shi, Doctor, 13791122810, shili126@sina.com

    Not yet recruiting
  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Xuezhong LI, Doctor, 18560083535, lxzebyh@163.com

    Not yet recruiting
  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Yongmei Yu, Master, 13888532131, yuyongmei@qq.com

    Not yet recruiting
  • Yunnan Provincial Hospital of Chinese Medicine

    Kunming, Yunnan, 650032

    Chunjiang Huang, Bachelor, 13888005188, huangchunjiang-1@163.com

    Not yet recruiting
  • Hebei PetroChina Central Hospital

    Langfang, Hebei, 65000

    Jianbing Li, Bachelor, 13785658534, caoyu200211@souhu.com

    Not yet recruiting
  • Hebei Provincial People's Hospital

    Shijiazhuang, Hebei, 050051

    Yongtao Qu, Doctor, 13171807631, 35288361@qq.com

    Not yet recruiting
  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, 50000

    Feng Luan, Master, 18533112937, lfydsylcsy@163.com

    Not yet recruiting
  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

    Huanping Zhang, 13994299030, zhp326@163.com

    Recruiting
  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

    Jixiang Liu, Bachelor, 13512056406, 13512056406@163.com

    Not yet recruiting
  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Yuping Yang, Doctor, 18999984998, 978288587@qq.com

    Not yet recruiting
  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

    Wei Liu, Doctor, 15327198392, cw99990@163.com

    Not yet recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of science and technology

    Wuhan, Hubei, 430022

    Jianjun Chen, Doctor, 13659851719, Ylly80331@163.com

    Not yet recruiting
  • Tongji Hospital of Tongji medical college of HUST

    Wuhan, Hubei, 430030

    Rongfei Zhu, Doctor, 18986292602, zrf13092@163.com

    Not yet recruiting
  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Zheng Liu, Doctor, 18607110505, zhengliuent@hotmail.com

    Not yet recruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

    Kang Zhu, Master, 18991341809, zhukangent@163.com

    Not yet recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Fang Quan, Doctor, 13572056056, quanfang2013@163.com

    Not yet recruiting
  • Yan'an University Xianyang Hospital

    Xi'an, Shaanxi, 716000

    Ligang Zhang, Master, 15891651067, ligangzhang79@126.com

    Not yet recruiting
  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

    Yuemei Sun, Bachelor, 13256383919, sunym1963@sina.com

    Not yet recruiting
  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei, 075000

    Xiaoling Shang, Bachelor, 15530396553, xiaolingshang66@sina.com

    Not yet recruiting
  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

    Guangke Wang, Bachelor, 13598895398, 13598895398@163.com

    Not yet recruiting
  • Zibo Central Hospital

    Zibo, Shandong, 255036

    Daowen Song, Master, 18678186682, songdaoliang1971@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Being tested
TQH2722 injection
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).

Study groups in NCT07398859
Study groupRoleWhat they receive
TQH2722 injectionExperimentalInjection combined with TQH2722, 2 weeks as a treatment cycle.
Receives: Drug: TQH2722 injection

What is being measured

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

  1. Number of subjects with incidence of adverse event

    Adverse events occurring during treatment.

    Measured: Baseline up to 4 weeks

Secondary outcomes (26)
  1. Number of subjects with incidence of serious adverse event

    Serious adverse event occurring during treatment.

    Measured: Baseline up to 4 weeks

  2. Number of subjects with incidence of abnormality check indicators

    Number of subjects with incidence of abnormality check indicators: Abnormal examination indicators occurred during treatment.

    Measured: Baseline up to 4 weeks

  3. Retrospective nasal symptom score after treatment for 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.

    Measured: Baseline up to 2 weeks

  4. Retrospective nasal symptom score after treatment for 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.

    Measured: Baseline up to 4 weeks

  5. Mean daily morning retrospective total nasal symptom score

    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.

    Measured: Baseline up to 2 and 4 weeks

  6. Mean daily retrospective total nasal symptom score at night

    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.

    Measured: Baseline up to 2 and 4 weeks

  7. Total instantaneous nasal symptom score before medication in the morning every day

    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.

    Measured: Baseline up to 2 and 4 weeks

  8. Daily retrospective total nasal symptom score

    Mean percentage change from baseline in daily rTNSS at 2 weeks and 4 weeks of treatment.

    Measured: Baseline up to 2 and 4 weeks

  9. Total instantaneous nasal symptom score before medication in the morning every day

    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.

    Measured: Baseline up to 2 and 4 weeks

  10. Daily retrospective scoring of individual nasal symptoms

    Mean change from baseline in daily retrospective nasal single symptom scores at 2 weeks and 4 weeks of treatment.

    Measured: Baseline up to 2 and 4 weeks

  11. Daily retrospective nasal single symptom score during daytime

    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.

    Measured: Baseline up to 2 and 4 weeks

  12. Daily retrospective nasal single symptom score during night

    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.

    Measured: Baseline up to 2 and 4 weeks

  13. Daily retrospective total score of ocular symptoms

    Mean change from baseline in the retrospective Total Ocular Symptom Score (rTOSS) at 2 weeks or 4 weeks of treatment.

    Measured: Baseline up to 2 and 4 weeks

  14. Total score of retrospective ocular symptoms during daytime each day

    Mean change from baseline in the total daytime retrospective ocular symptom score (AM rTOSS) at 2 weeks and 4 weeks of treatment.

    Measured: Baseline up to 2 and 4 weeks

  15. Total score of retrospective ocular symptoms each night

    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.

    Measured: Baseline up to 2 and 4 weeks

  16. Total score of instantaneous ocular symptoms before medication in the morning every day

    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.

    Measured: Baseline up to 2 and 4 weeks

  17. Daily retrospective total score of ocular symptoms

    Mean percentage change in total retrospective ocular symptom score from baseline at 2 weeks and 4 weeks of treatment, respectively.

    Measured: Baseline up to 2 and 4 weeks

  18. Total score of instantaneous ocular symptoms before medication each morning

    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.

    Measured: Baseline up to 2 and 4 weeks

  19. Daily retrospective scoring of individual ocular symptoms

    Mean change in individual ocular symptom scores from baseline to 2 weeks and 4 weeks after treatment, retrospectively assessed daily.

    Measured: Baseline up to 2 and 4 weeks

  20. Daily retrospective scoring of individual ocular symptoms during the day

    Mean change from baseline in retrospective ocular symptom scores during daytime (AM) on each day at 2 weeks and 4 weeks of treatment.

    Measured: Baseline up to 2 and 4 weeks

  21. Nightly retrospective scoring of individual ocular symptoms

    Mean change from baseline in retrospective ocular symptom scores at night (PM) at 2 weeks and 4 weeks of treatment

    Measured: Baseline up to 2 and 4 weeks

  22. Quality of Life Questionnaire Score for Patients with Allergic Rhinitis

    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.

    Measured: Baseline up to 2 and 4 weeks

  23. Daily retrospective total score of nasal symptoms

    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.

    Measured: Baseline up to 2 and 4 weeks

  24. Blood eosinophil count and percentage

    Changes in eosinophil count and percentage from baseline, as well as the percentage of change, at each evaluation visit point.

    Measured: Baseline up 12 weeks

  25. Serum total immunoglobulin E concentration

    The changes in serum total immunoglobulin E concentration and the percentage of change from baseline at each evaluation visit point.

    Measured: Baseline up 12 weeks

  26. Forced expiratory volume in 1 second (FEV1) before bronchodilator administration (BD) in subjects with concomitant asthma

    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.

    Measured: Baseline up 12 week

Timeline

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

  1. First posted10 Feb 2026
  2. Study start19 Mar 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionMar 2027 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07398859
Sponsor's protocol ID
TQH2722-II-06
Status last verified
Nov 2025
First submitted
3 Feb 2026
Last updated
27 Mar 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 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 10 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 27 Mar 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Zheng Liu, Doctor (18607110505, zhengliuent@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with incidence of adverse event (time frame: Baseline up to 4 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 27 Mar 2026.

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