Phase
Condition
Allergy
Common Cold
Nasal Obstruction
Treatment
TQH2722 Placebo
TQH2722 injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Peking University First Hospital
Beijing, Beijing 100034
ChinaSite Not Available
Peking University People's Hospital
Beijing, Beijing 100044
ChinaSite Not Available
Peking University Third Hospital
Beijing, Beijing 100191
ChinaSite Not Available
Gansu Provincial Hospital
Lanzhou, Gansu 730000
ChinaSite Not Available
Cangzhou Central Hospital
Cangzhou, Hebei 061017
ChinaSite Not Available
Hebei Medical University Third Hospital
Shijiazhuang, Hebei 50000
ChinaSite Not Available
Henan Provincial People's Hospital
Zhengzhou, Henan 450000
ChinaSite Not Available
The Central Hospital of Wuhan
Wuhan, Hubei 430014
ChinaSite Not Available
Tongji Hospital of Tongji medical college of HUST
Wuhan, Hubei 430030
ChinaSite Not Available
Union Hospital, Tongji Medical College, Huazhong University of science and technology
Wuhan, Hubei 430022
ChinaSite Not Available
Zhongnan Hospital of Wuhan University
Wuhan, Hubei 430071
ChinaActive - Recruiting
Baotou Central Hospital
Baotou, Inner Mongolia 014000
ChinaSite Not Available
Chifeng Municipal Hospital
Chifeng, Inner Mongolia 024005
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia 015000
ChinaSite Not Available
Ansteel Group General hospital
Anshan, Liaoning 114000
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110004
ChinaSite Not Available
Liaoning Health Industry Group Iron Coal General Hospital
Tieling, Liaoning 112700
ChinaSite Not Available
The First People's Hospital of Yinchuan
Yinchuan, Ningxia 750000
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710004
ChinaSite Not Available
Shandong Second Provincial General Hospital
Jinan, Shandong 250000
ChinaSite Not Available
Qilu Hospital of Shandong University
Qilu, Shandong 250012
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai, Shandong 264000
ChinaSite Not Available
Zibo Central Hospital
Zibo, Shandong 255036
ChinaSite Not Available
Shanxi Bethune Hospital
Taiyuan, Shanxi 030000
ChinaSite Not Available
Tianjin First Central Hospital
Tianjin, Tianjin 300192
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, Tianjin 300041
ChinaSite Not Available
Tianjin People's Hospital
Tianjin, Tianjin 300121
ChinaSite Not Available
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang 830054
ChinaSite Not Available
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650032
ChinaSite Not Available
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