Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis
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
1 other identifier
interventional
300
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedStudy Start
First participant enrolled
March 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 27, 2026
November 1, 2025
8 months
February 3, 2026
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with incidence of adverse event
Adverse events occurring during treatment.
Baseline up to 4 weeks
Secondary Outcomes (26)
Number of subjects with incidence of serious adverse event
Baseline up to 4 weeks
Number of subjects with incidence of abnormality check indicators
Baseline up to 4 weeks
Retrospective nasal symptom score after treatment for 2 weeks
Baseline up to 2 weeks
Retrospective nasal symptom score after treatment for 4 weeks
Baseline up to 4 weeks
Mean daily morning retrospective total nasal symptom score
Baseline up to 2 and 4 weeks
- +21 more secondary outcomes
Study Arms (1)
TQH2722 injection
EXPERIMENTALInjection combined with TQH2722, 2 weeks as a treatment cycle.
Interventions
TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Hebei University Affiliated Hospital
Baoding, Hebei, 071000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061017, China
Hebei PetroChina Central Hospital
Langfang, Hebei, 65000, China
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, 050051, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 50000, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 075000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
Union Hospital, Tongji Medical College, Huazhong University of science and technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji medical college of HUST
Wuhan, Hubei, 430030, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Yan'an University Xianyang Hospital
Xi'an, Shaanxi, 716000, China
Shandong Second Provincial General Hospital
Jinan, Shandong, 250000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zibo Central Hospital
Zibo, Shandong, 255036, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610000, China
Second People's Hospital of Chengdu
Chengdu, Sichuan, 610000, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Yunnan Provincial Hospital of Chinese Medicine
Kunming, Yunnan, 650032, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2026
First Posted
February 10, 2026
Study Start
March 19, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
March 27, 2026
Record last verified: 2025-11