A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.

Sinusitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089278
• Other study ID #: TQH2722-II-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2023
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Luo Zhang, Doctor
• Phone: +86 13910830399
• Email: dr.luozhang[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness, safety and pharmacokinetics of TQH2722 injection in patients with chronic sinusitis with or without nasal polyps.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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:

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.

Related Conditions & MeSH terms

• Nasal Polyps
• Sinusitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongolia
China	Beijing Hospital	Beijing	Beijing
China	Beijing TongRen Hospital, Capital Medical University	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	Jilin Province People's Hospital	Changchun	Jilin
China	Chengdu Second People's Hospital	Chengdu	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The Affiliated hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Jieyang People's Hospital	Jieyang	Guangdong
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Central Hospital of Shenyang Medical College	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Hebei Medical University Third Hospital	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Taizhou central hospital	Taizhou	Zhejiang
China	Wenling First People's Hospital	Taizhou	Zhejiang
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Weifang Second People's Hospital	Weifang	Shandong
China	Weihai Central Hospital	Weihai	Shandong
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	The Affiliated Hospital of Yanbian University	Yanji	Jilin
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Zibo Central Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in nasal polyp score	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.	Up to 16 weeks.
Primary	Changes in sinus CT scan Lund Mackay score in Part B	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.	Up to 16 weeks.
Secondary	Changes in sinus CT scan Lund Mackay score in Part A	Changes in sinus CT scan Lund Mackay score in subjects with chronic sinusitis without nasal polyps (CRSsNP) from baseline in Part A. The total score is 0-24 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in the Lund-Kennedy score by nasal endoscopy	Changes in subjects' nasal endoscopy modified Lund-Kennedy score from baseline. The total score is 0-20 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in University of Pennsylvania Smell Identification Test (UPSIT)	Changes in University of Pennsylvania Smell Identification Test (UPSIT) of patients from baseline. The total score is 0-40 points, with the lower score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in Nasal Total Symptom Score (sTSS)	Changes in subjects' Nasal Total Symptom Score (sTSS) from baseline. The total score is 0-9 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in the Anosmia score	Changes in subjects' Anosmia scores from baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in nasal congestion score (NCS)	Change in subjects' Nasal congestion Score (NCS) from baseline at week 16. The total score is 0-3 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in nasal/post-nasal discharge scores	Changes in subjects' nasal/post-nasal discharge scores from baseline at week 16. The total score is 0-3 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in facial pain/pressure scores	Changes in subjects' facial pain/pressure scores from baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in the Visual analogue Scale (VAS) of sinusitis	Changes in the Visual Analogue Scale (VAS) for sinusitis in subjects from baseline. The total score is 0-10 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Subjects' Health-related Quality of Life (HRQoL) questionnaire	Effects of Subjects' Health-related Quality of Life (HRQoL) from baseline. The total score is 0-100 points, with the higher score meaning the more severe symptoms.	Up to 16 weeks.
Secondary	Changes in nasal peak inspiratory flow rate (NPIF)	Changes in the subject's nasal peak inspiratory flow rate (NPIF) from baseline	Up to 16 weeks.
Secondary	Systemic glucocorticoid (SCS) remedial or surgical treatment rate	Proportion of patients receiving systemic glucocorticoid (SCS) remedial or surgical treatment during 16 weeks	Up to 16 weeks.
Secondary	Incidence of adverse events	Incidence of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators	Up to 24 weeks.
Secondary	Severity of adverse events	Severity of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators	Up to 24 weeks.
Secondary	Peak concentration (Cmax)	Maximum plasma drug concentration	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.
Secondary	Trough concentration (Cmin)	Minimum plasma drug concentration	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.
Secondary	Peak time (Tmax)	The time required to reach peak concentration after administration	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.
Secondary	Area under blood concentration-time curve (AUC0-t)	The area enclosed by the blood concentration curve to the timeline	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.
Secondary	Steady-state peak concentration (Css-max)	The highest blood concentration that occurs in steady state	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.
Secondary	Steady-state valley concentration (Css-min)	The lowest blood concentration that occurs in steady state	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.
Secondary	Mean steady-state blood concentration (Css-av)	The quotient obtained by dividing the area under the blood concentration-time curve by the interval time t during a dose interval when the blood concentration reaches a steady state	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.
Secondary	Steady-state peak time (Tss-max)	The time required to reach peak steady-state concentration after administration	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.
Secondary	Area under steady state blood concentration-time curve (AUC ss,0-t)	Area under the blood concentration-time curve in steady state	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.
Secondary	Elimination half-life	The time it takes for half the drug to be eliminated from the body	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.
Secondary	Apparent volume of distribution (Vd/F)	The ratio of the amount of drug in the body to the concentration in the blood after the drug has reached homeostasis in the body	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.
Secondary	Clearance rate (CL/F)	Per unit time, the volume of drug-containing liquid is completely and effectively removed by the elimination organ	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.