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This is a multicenter, randomized, continuing, Phase II expansion trial to evaluate the safety, efficacy, and immunogenicity of two doses of TQH2722 in the long-term treatment of severe chronic sinusitis with or without nasal polyps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300mg/600mg of TQH2722 injection in Part A or B | Experimental | For Part A or Part B, 300mg/600mg of TQH2722 injection was administered every 2 weeks until week 22, combined with Mometasone furoate nasal spray of 100-200μg/ day until week 32. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300mg/600mg of TQH2722 injection | Drug | TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events (TEAE) | Frequency of treatment emergent adverse events (TEAE) occurring during treatment. | Up to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events (SAEs) | The frequency of serious adverse events (SAEs) that occurred during treatment in subjects with chronic sinusitis with nasal polyps (CRSwNP) or chronic sinusitis without nasal polyps (CRSsNP). | Up to 32 weeks |
| Abnormal laboratory test indicators |
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Inclusion Criteria:
Inclusion Criteria of Part A
Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
Age 18-75 years old (including the threshold), male or female;
Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" :
Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study.
Inclusion Criteria of Part B
Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
Age 18-75 years old (including the threshold), male or female;
Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" :
Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study.
Exclusion Criteria:
In the main study (TQH2722-II-02), a TQH2722-related SAE occurred or TQH2722-related AE led to the discontinuation of TQH2722 therapy, and after discussion between the investigator and sponsor, the subject was deemed unsuitable for continuation of TQH2722 therapy.
The subjects had poor compliance in the main study, and the researchers judged that they could not complete the continuing study.
During the main study (TQH2722-II-02), any severe progression or poorly controlled concomitant disease (such as asthma exacerbation requiring adjustment of background medication) is identified and the subject is deemed unfit to participate by the principal investigator;
Any of the following laboratory test values are abnormal during the screening period:
Any medical condition, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major limb disorders, that the investigator believes is unstable and may affect the patient's safety throughout the study period, or affect the study results or their interpretation, or interfere with the patient's ability to complete the entire study process.For example, but not limited to: ischemic heart disease, left ventricular failure, arrhythmia, uncontrolled hypertension, uncontrolled hyperglycemia, cerebrovascular disease, etc.;
Patients with active autoimmune diseases (including, but not limited to, Hashimoto thyroiditis, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis and other neuroinflammatory diseases, psoriasis vulgaris, rheumatoid arthritis);
Known or suspected immunosuppressed individuals, including but not limited to a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cyst disease, aspergillosis), even if the infection has resolved;
Subjects with active malignant tumors or a history of malignant tumors:Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ who had completed curative treatment for at least 12 months prior to visit 1 could be enrolled in this study; patients with other malignancies could be enrolled if they had completed curative treatment for at least 5 years prior to visit 1;
A history of active pulmonary tuberculosis within 12 months prior to screening;
Active hepatitis was present at the screening stage, either hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and Hepatitis B Virus-DNA positive, or Hepatitis C Virus (HCV) antibody positive and HCV-RNA positive; or human immunodeficiency virus (Anti-HIV) positive, or treponema pallidum antibody (Anti-TP) positive (if the treponema pallidum serological test is positive, then further non-treponema pallidum serological test is performed, the latter is negative and the investigator determines that patients who have been infected with syphilis in the past but have been cured are eligible for inclusion);
Diagnosis of helminthic infection within 6 months prior to the screening period, failure to receive standard treatment or failure to respond to standard treatment;
Subjects who received the following treatments:
Patients with asthma should be excluded if: a. forced expiratory volume in the first second (FEV1) ≤ 50% of the expected normal value, or b.Acute exacerbation of asthma within 90 days prior to screening requiring hospitalization (>24 hours), or c.Are using a daily dose of fluticasone or equivalent inhaled glucocorticoids (ICS) greater than 1000mcg;
Subjects with asthma were initiated with inhaled corticosteroids within 4 weeks prior to the screening/induction period (for subjects who could receive a stable dose for at least 4 weeks prior to screening and whose assessed dose could be maintained throughout the study period, inhaled corticosteroids could be fluticasone propionate at a dose ≤1000μg or equivalent doses of other inhaled corticosteroids).
Subjects have concomitant medical conditions that prevent them from completing the screening period assessment or evaluating the primary efficacy endpoint, such as:
Subjects with nasal malignancies and benign tumors (e.g., papilloma, hemangioma, etc.);
Subjects who are unable to use MFNS or are allergic or intolerant to Mometasone furoate nasal spray;
Subjects with a history of systemic allergy to any biological agent (except local injection site reactions);
Pregnant or lactating women;
Alcohol, drug and known drug dependence;
The subjects had poor compliance in the study and could not complete the study as judged by the researcher;
Any medical or psychiatric condition that, in the judgment of the investigator or sponsor medical reviewer, puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of the study results.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luo Zhang, Postdoctoral | Contact | 13910830399 | dr.luozhang@139.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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Abnormal laboratory test indicators during treatment in subjects with chronic sinusitis with nasal polyps (CRSwNP) or chronic sinusitis without nasal polyps (CRSsNP). |
| Up to 32 weeks |
| Changes in Lund Mackay score assessed by CT from baseline | Change in Lund Mackay score assessed by CT from baseline. The total score is 0-24 points, with the higher score meaning the more severe symptoms. | Up to 24 weeks |
| Changes in the University of Pennsylvania Smell Identification Test (UPSIT) | The change in the University of Pennsylvania Smell Identification Test (UPSIT) from baseline (main study TQH2722-II-02 and baseline in this study, respectively) at each evaluation time point. | Up to 32 weeks |
| Changes in Nasal Total Symptom Score from baseline | Changes in subjects' Nasal Total Symptom Score from baseline. The total score is 0-9 points, with the higher score meaning the more severe symptoms. | Up to 32 weeks |
| Changes in the sinusitis Visual Analogue Scale (VAS) score from baseline | Changes in the sinusitis Visual Analogue Scale (VAS) score from baseline were measured at each evaluation time point. The total score is 0-10 points, with the higher score meaning the more severe symptoms. | Up to 32 weeks |
| Immunogenicity: The incidence of drug-resistant antibodies (ADA) and their titers, and the incidence of neutralizing antibodies (Nab). | Immunogenicity: The incidence of drug-resistant antibodies (ADA) and their titers, and the incidence of neutralizing antibodies (Nab) in subject. If the subject tests positive for ADA, neutralizing antibodies are added. | 0h (The first dose), D113, D169 and during withdrawal |
| Changes in nasal polyp scores of subjects with chronic sinusitis with nasal polyps (CRSwNP) in part A | Changes in nasal polyp scores of subjects with chronic sinusitis with nasal polyps (CRSwNP) at each evaluation time point were compared with baseline values (TQH2722-II-02 in the main study and baseline values in this study, respectively). | Weekends 0, 8, 16, 24 and 32 |
| Changes in Sino-nasal Outcome Test (SNOT-22) in part A | Changes in Sino-nasal Outcome Test (SNOT-22) from baseline for subjects at each evaluation time point. | Weekends 0, 8, 16, 24 and 32 |
| Changes in nasal congestion score (NCS) in part A from baseline | The changes in nasal congestion score (NCS) from baseline at each evaluation time point in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Up to 32 weeks |
| Changes in nasal/posterior runny nose scores in part A from baseline | Changes in subjects' nasal/posterior runny nose scores from baseline at each evaluation time point. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Up to 32 weeks |
| Changes in the anosmia score in part A from baseline | The changeS in the anosmia score from baseline at each evaluation time point in part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Up to 32 weeks |
| Changes of olfactory loss score in part B from baseline | In Part B, the change of subjects' olfactory loss score from baseline (using the main study TQH2722-II-02 and the baseline value in this study, respectively) at each evaluation time point. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Up to 32 weeks |
| Changes in nasal endoscopic modified Lund-Kennedy scores in part B | In Part B, changes in subjects' nasal endoscopic modified Lund-Kennedy scores from baseline (using the main study TQH2722-II-02 and the baseline in this study, respectively) at each evaluation time point are measured. The total score is 0-24 points, with the higher score meaning the more severe symptoms. | Weekends 0, 8, 16, 24 and 32 |
| Changes in Sino-nasal Outcome Test (SNOT-22) in part B | In Part B, change from baseline in Sino-nasal Outcome Test (SNOT-22) for subjects at each evaluation time point. | Weekends 0, 8, 16, 24 and 32 |
| The First People's Hospital of Foshan | Not yet recruiting | Foshan | Guangdong | 528000 | China |
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| The Second People's Hospital of Shenzhen | Not yet recruiting | Shenzhen | Guangdong | 518035 | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Hebei Medical University Third Hospital | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Cangzhou Central Hospital | Not yet recruiting | Cangzhou | Heibei | 061017 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of science and technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Renmin Hospital of Wuhan University Hubei General Hospital | Not yet recruiting | Wuhan | Hubei | 430060 | China |
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| Loudi Central Hospital | Not yet recruiting | Changsha | Hunan | 417000 | China |
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| Baotou Central Hospital | Not yet recruiting | Baotou | Inner Mongolia | 014000 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
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| Jilin Provincial People's Hospital | Not yet recruiting | Changchun | Jilin | 130021 | China |
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| The Affiliated Hospital of Yanbian University | Not yet recruiting | Yanji | Jilin | 133002 | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110002 | China |
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| Shengjing Hospital Affiliated to China Medical University | Not yet recruiting | Shenyang | Liaoning | 110004 | China |
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| The Central Hospital of Shenyang Medical College | Not yet recruiting | Shenyang | Liaoning | 110075 | China |
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| Shandong Second People's Hospital | Not yet recruiting | Jinan | Shandong | 250299 | China |
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| Weihai Central Hospital | Not yet recruiting | Weihai | Shandong | 264499 | China |
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| Yantai Yuhuangding Hospital | Not yet recruiting | Yantai | Shandong | 264000 | China |
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| Zibo Central Hospital | Not yet recruiting | Zibo | Shandong | 255036 | China |
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| Zibo Central Hospital | Not yet recruiting | Zibo | Shandong | 255036 | China |
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| Renji Hospital Shanghai Jiaotong University School of Medical | Not yet recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| First Hospital of Shangxi Medical University | Not yet recruiting | Taiyuan | Shangxi | 030001 | China |
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| Chengdu Second People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610021 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830011 | China |
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| Taizhou central hospital(Taizhou university hospital) | Not yet recruiting | Taizhou | Zhejiang | 318000 | China |
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| Wenling First People's Hospital | Not yet recruiting | Wenling | Zhejiang | 317599 | China |
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