A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC2938 Injection Combined With Background Therapy in Patients With Seasonal Allergic Rhinitis

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate TQC2938 injection in all patients receiving background treatment with azelastine fluticasone nasal spray. The efficacy, safety and immunogenicity of the injection in patients with seasonal allergic rhinitis compared with placebo are expected to include 136 patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 Specific Absorption Rate (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 ≥6; At baseline visit, the morning iTNSS was ≥6 points, and the average score of the past 6 rTNSS was ≥6 points;

• 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.

Locations
Other Locations
China
Baotou Central Hospital
NOT_YET_RECRUITING
Baotou
Beijing TongRen Hospital, Capital Medical University
RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Cangzhou central hosipital
NOT_YET_RECRUITING
Cangzhou
China-japan Friendship Hospital, Jilin University
NOT_YET_RECRUITING
Changchun
The first hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Affiliated Zhongshan Hospital Of Dalian university
NOT_YET_RECRUITING
Dalian
First Affiliated Hospital, Heilongjang University of Chinese Medigine
NOT_YET_RECRUITING
Harbin
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
The Second People's Hospital of Shandong Province
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
Ganzu Province People's Hospital
NOT_YET_RECRUITING
Lanzhou
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Hebei Medical University Third Hospital
NOT_YET_RECRUITING
Shijiazhuang
First Hospital of Shangxi Medical University
NOT_YET_RECRUITING
Taiyuan
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin First Central Hospital
NOT_YET_RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Tongji Hospital of Tongji medical college of HUST
NOT_YET_RECRUITING
Wuhan
Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
NOT_YET_RECRUITING
Xi'an
Northern Jiangsu People'S Hospital
NOT_YET_RECRUITING
Yangzhou
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
General Hospital of Ningxia Medical University
NOT_YET_RECRUITING
Yinchuan
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
People'S Hospital of Zhengzhou
NOT_YET_RECRUITING
Zhengzhou
Zhengzhou Central Hospital
NOT_YET_RECRUITING
Zhengzhou
Zibo Central Hospital
NOT_YET_RECRUITING
Zibo
Contact Information
Primary
Luo Zhang, Doctor
dr.louzhang@139.com
13910830399
Backup
Chengshuo Wang, Doctor
wangcs830@126.com
13911623569
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 136
Treatments
Experimental: TQC2938 injection
TQC2938 injection, 4 weeks as a treatment cycle.
Placebo_comparator: TQC2938 Placebo
TQC2938 placebo, 4 weeks as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov