NCT06089278已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials to Assess the Effectiveness, Safety and Pharmacokinetics of TQH2722 Injection in Patients With Chronic Sinusitis With or Without Nasal Polyps.
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.36 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年12月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 36
- 主要终点
- Changes in nasal polyp score in Part A
研究概览
简要总结
To evaluate the effectiveness, safety and pharmacokinetics of TQH2722 injection in patients with chronic sinusitis with or without nasal polyps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old, gender is not limited;
- •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).
排除标准
- •Any disease that the investigator considers unstable and may affect the patient's safety throughout the study period, or affect or interpretation with the results, or interfere with the patient's ability to complete the entire research process, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic diseases, psychiatric disorders, or major limb disorders. For example, but not limited to: ischemic heart disease, left ventricular failure, arrhythmia, uncontrolled hypertension, uncontrolled hyperglycemia, cerebrovascular disease, etc.;
- •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:
- •Forced expiratory volume in the first second (FEV1) ≤ 50% of normal estimates, or
- •Acute exacerbation of asthma within 90 days prior to screening, requiring hospitalization (>24 hours), or
- •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.
研究组 & 干预措施
600mg of TQH2722 injection
Experimental
TQH2722 injection, 14 days as a treatment cycle.
干预措施: 600mg of TQH2722 injection (Drug)
300mg of TQH2722 injection
Experimental
TQH2722 injection, 14 days as a treatment cycle.
干预措施: 300mg of TQH2722 injection (Drug)
TQH2722 injection matching placebo
Placebo Comparator
TQH2722 injection matching placebo, 14 days as a treatment cycle.
干预措施: TQH2722 injection matching placebo (Drug)
结局指标
主要结局
Changes in nasal polyp score in Part A
时间窗: Up to 16 weeks.
Changes in nasal polyp score in subjects with chronic sinusitis with nasal polyps (CRSwNP) from baseline. The total score is 0-9 points, with the higher score meaning the more severe symptoms.
Changes in sinus CT scan Lund Mackay score in Part B
时间窗: Up to 16 weeks.
Changes in sinus CT scan Lund Mackay score in subjects with chronic sinusitis without nasal polyps (CRSsNP) from baseline in Part B. The total score is 0-24 points, with the higher score meaning the more severe symptoms.
次要结局
- Changes in University of Pennsylvania Smell Identification Test (UPSIT)(Up to 16 weeks.)
- Changes in the Lund-Kennedy score by nasal endoscopy(Up to 16 weeks.)
- Changes in nasal peak inspiratory flow rate (NPIF)(Up to 16 weeks.)
- Systemic glucocorticoid (SCS) remedial or surgical treatment rate(Up to 16 weeks.)
- Incidence of adverse events(Up to 24 weeks.)
- Changes in Nasal Total Symptom Score (sTSS)(Up to 16 weeks.)
- Changes in the Visual analogue Scale (VAS) of sinusitis(Up to 16 weeks.)
- Subjects' Health-related Quality of Life (HRQoL) questionnaire(Up to 16 weeks.)
- Changes in sinus CT scan Lund Mackay score in Part A(Up to 16 weeks.)
- Changes in nasal congestion score (NCS)(Up to 16 weeks.)
- Changes in nasal/post-nasal discharge scores(Up to 16 weeks.)
- Changes in facial pain/pressure scores(Up to 16 weeks.)
- Trough concentration (Cmin)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Steady-state peak concentration (Css-max)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Changes in the Anosmia score(Up to 16 weeks.)
- Steady-state peak time (Tss-max)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Elimination half-life(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Apparent volume of distribution (Vd/F)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Severity of adverse events(Up to 24 weeks.)
- Peak time (Tmax)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Area under blood concentration-time curve (AUC0-t)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Peak concentration (Cmax)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Steady-state valley concentration (Css-min)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Mean steady-state blood concentration (Css-av)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Area under steady state blood concentration-time curve (AUC ss,0-t)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
- Clearance rate (CL/F)(Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.)
研究者
研究点 (36)
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