Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: TQH2722 injection; Drug: TQH2722 Placebo

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Gansu Provincial Hospital
  • Hebei
    • Cangzhou, Hebei, China, 061017
      • Cangzhou Central Hospital
    • Shijiazhuang, Hebei, China, 50000
      • Hebei medical university third hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China, 430014
      • The Central Hospital of Wuhan
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College of HUST
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014000
      • Baotou Central Hospital
    • Chifeng, Inner Mongolia, China, 024005
      • Chifeng Municipal Hospital
    • Hohhot, Inner Mongolia, China, 015000
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Liaoning
    • Anshan, Liaoning, China, 114000
      • Ansteel Group General Hospital
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
    • Tieling, Liaoning, China, 112700
      • Liaoning Health Industry Group Iron Coal General Hospital
  • Ningxia
    • Yinchuan, Ningxia, China, 750000
      • The First People's Hospital of Yinchuan
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250000
      • Shandong Second Provincial General Hospital
    • Qilu, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Yantai, Shandong, China, 264000
      • Yantai Yuhuangding Hospital
    • Zibo, Shandong, China, 255036
      • Zibo Central Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Bethune Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300121
      • Tianjin People's Hospital
    • Tianjin, Tianjin, China, 300192
      • Tianjin First Central Hospital
    • Tianjin, Tianjin, China, 300041
      • Tianjin Medical University General Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First Affiliated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;
• 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

Exclusion Criteria:

• 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;
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQH2722 injection	Drug: TQH2722 injection; TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).
Placebo Comparator: TQH2722 Placebo; TQH2722 placebo, 1 weeks as a treatment cycle.	Drug: TQH2722 Placebo; Placebo without drug substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 4 weeks
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.	Baseline up to 2 and 4 weeks
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	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
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.	Baseline up to 2 and 4 weeks
Time of onset	Time of onset after treatment.	Baseline up to 4 weeks
Time to Reach Maximum Plasma Concentration (Tmax)	Time to reach maximum plasma concentration after administration.	Baseline up to 4 weeks
Area under the curve	Area under the curve of mean daily rTNSS change from baseline at 2 and 4 weeks of treatment	Baseline up to 2 and 4 weeks
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	Baseline up to 2 and 4 weeks
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.	Baseline up to 12 weeks

Collaborators and Investigators

• Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: TQH2722-II-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No