A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.
NCT ID: NCT06089278
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2023-12-28
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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300mg of TQH2722 injection
TQH2722 injection, 14 days as a treatment cycle.
300mg of TQH2722 injection
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
600mg of TQH2722 injection
TQH2722 injection, 14 days as a treatment cycle.
600mg of TQH2722 injection
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
TQH2722 injection matching placebo
TQH2722 injection matching placebo, 14 days as a treatment cycle.
TQH2722 injection matching placebo
Placebo without active substance.
Interventions
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300mg of TQH2722 injection
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
600mg of TQH2722 injection
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
TQH2722 injection matching placebo
Placebo without active substance.
Eligibility Criteria
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Inclusion Criteria
* Bilateral chronic sinusitis (with or without nasal polyps) that meets the diagnostic criteria of The Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2018);
* Systemic corticosteroids (at least 1 course of prednisone 0.5 to 1 mg/kg/day or equivalent for at least 5 days) within 2 years prior to the screening, but bilateral chronic sinusitis still exist; and/or patients with drug contraindications/intolerance to systemic glucocorticoids, and (or) patients who have undergone sinus surgery within 6 months before the screening;
* Before the screening, subjects must have used a stable dose of intranasal corticosteroids (INCS) for more than 4 weeks; For participants who used INCS alternatives rather than Mometasone furoate nasal spray (MFNS) prior to screening, participants should be willing to switch to MFNS in the duration of the study;
* Subjects with asthma started inhaled glucocorticoids at a stable dose at least 4 weeks before the screening and could remain inhaled glucocorticoid doses unchanged throughout the study;
* Patients in the Run-in period should be willing to conduct diary, daily symptom assessment and maintain a stable dose of MFNS with at least 70% adherence;
* Be able to read and understand, and be willing to sign informed consent;
* Participants and their partners agreed to use effective contraception throughout the study period (from the beginning of the screening/run-in period to 3 months after the last dose).
Exclusion Criteria
* Patients with active autoimmune disease;
* Known or suspected immunosuppressed, including but not limited to invasive opportunistic infections
* Subjects with active malignant tumors or a history of malignant tumors;
* History of active pulmonary tuberculosis within the 12 months before screening;
* Active hepatitis during the screening period, or positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and positive hepatitis B virus (HBV) DNA, or positive hepatitis C virus (HCV) antibody and positive HCV-RNA; or positive for antibodies to human immunodeficiency virus (Anti-HIV) or positive for treponemal antibodies (Anti-TP);
* Diagnosed with helminth parasitic infection within 6 months before the screening period, did not receive standard treatment or the standard treatment was ineffective;
* Patients with combined asthma should be excluded if they have:
1. Forced expiratory volume in the first second (FEV1) ≤ 50% of normal estimates, or
2. Acute exacerbation of asthma within 90 days prior to screening, requiring hospitalization (\>24 hours), or
3. used daily doses higher than 1000 mcg of fluticasone or equivalent inhaled corticosteroids (ICS);
* The subject had concomitant diseases that prevented him/her from completing the screening period assessment or from evaluating the primary efficacy endpoint;
* Subjects with nasal malignancies and benign tumors (e.g., papillomas, hemangiomas, etc.);
* Subjects who are unable to use MFNS or who are allergic or intolerant to mometasone furoate nasal spray;
* Subjects with a history of anaphylaxis to any biological agent (other than local injection site reactions);
* Pregnant or lactating women;
* Alcoholism, drug addiction and known drug dependence;
* Have participated in clinical trials of other medical devices within 12 weeks before screening;
* The subject had poor compliance in the research and could not complete the study as judged by the investigator;
* In the judgment of the investigator or sponsoring medical reviewer, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing TongRen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Foshan First People's Hospital
Foshan, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Affiliated hospital of Guizhou Medical University
Guiyang, Guizhou, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Union Hospitalc, Tongji Medical College, Huazhong, University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Loudi Central Hospital
Changsha, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Jilin Province People's Hospital
Changchun, Jilin, China
The Affiliated Hospital of Yanbian University
Yanji, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Central Hospital of Shenyang Medical College
Shenyang, Liaoning, China
Shandong Second People's Hospital
Jinan, Shandong, China
Weifang Second People's Hospital
Weifang, Shandong, China
Weihai Central Hospital
Weihai, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Wenling First People's Hospital
Taizhou, Zhejiang, China
Taizhou central hospital
Taizhou, Zhejiang, China
Countries
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Other Identifiers
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TQH2722-II-02
Identifier Type: -
Identifier Source: org_study_id
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