Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis

Last updated: March 13, 2025
Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

TQH2722 Placebo

TQH2722 injection

Clinical Study ID

NCT06760182
TQH2722-II-05
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 to 75 years at the screening period.

  • Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelinesfor the Diagnosis and Treatment of Allergic Rhinitis (revised edition, 2022)

  • Positive of at least 1 allergen skin prick test(SPT) and/or serum-specific IgEwithin 1 year before enrollment.

  • Subjects have sufficient pollen exposure during the pollen season:

  • Subjects' medical history suggested that SAR symptoms were poorly controlled orsubjects' subjective symptoms were not satisfactorily controlled after drugtreatment 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 ≥6points;

  • 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 havingstable asthma;

  • Voluntary participation in this trial and signing the informed consent form

  • Subjects (including partners) have no pregnancy and voluntarily take one or morenon-pharmaceutical measures for contraception at period from drug administration to 6 months after the last study drug administration

Exclusion

Exclusion Criteria:

  • Laboratory test values did not meet the requirements during screening orrandomization

  • Any disease that the investigator believes interferes with the patient's ability tocomplete 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 humanimmunodeficiency virus antibody (Anti-HIV) positive, or treponema pallidum antibody (Anti-TP) positive;

  • Diagnosis of helminthic infection within 6 months prior to screening, not receivingstandard treatment or not responding to standard treatment;

  • Subjects who have undergone nasal surgery or sinus surgery within 6 months beforescreening

  • Subjects have concomitant medical conditions that preclude them from completing thescreening 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 marrowtransplantation;

  • Any medical or psychiatric condition that, in the investigator's judgment, puts thesubject at risk, interferes with participation in the study, or interferes with theinterpretation of the study results;

  • Any condition that the investigator or primary physician believes may not beappropriate for participating the study

Study Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: TQH2722 Placebo
Phase: 2
Study Start date:
March 10, 2025
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Cangzhou Central Hospital

    Cangzhou, Hebei 061017
    China

    Site Not Available

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei 50000
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The Central Hospital of Wuhan

    Wuhan, Hubei 430014
    China

    Site Not Available

  • Tongji Hospital of Tongji medical college of HUST

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Union Hospital, Tongji Medical College, Huazhong University of science and technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430071
    China

    Active - Recruiting

  • Baotou Central Hospital

    Baotou, Inner Mongolia 014000
    China

    Site Not Available

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia 024005
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 015000
    China

    Site Not Available

  • Ansteel Group General hospital

    Anshan, Liaoning 114000
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Liaoning Health Industry Group Iron Coal General Hospital

    Tieling, Liaoning 112700
    China

    Site Not Available

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia 750000
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710004
    China

    Site Not Available

  • Shandong Second Provincial General Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Qilu, Shandong 250012
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264000
    China

    Site Not Available

  • Zibo Central Hospital

    Zibo, Shandong 255036
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Tianjin First Central Hospital

    Tianjin, Tianjin 300192
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300041
    China

    Site Not Available

  • Tianjin People's Hospital

    Tianjin, Tianjin 300121
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830054
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.