Clinical trial NCT06089278: A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sinusitis
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in nasal polyp score in Part A
timeFrame: Up to 16 weeks.
measure: Changes in sinus CT scan Lund Mackay score in Part B
timeFrame: Up to 16 weeks.
Secondary outcomes:
measure: Changes in sinus CT scan Lund Mackay score in Part A
timeFrame: Up to 16 weeks.
measure: Changes in the Lund-Kennedy score by nasal endoscopy
timeFrame: Up to 16 weeks.
measure: Changes in University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: Up to 16 weeks.
measure: Changes in Nasal Total Symptom Score (sTSS)
timeFrame: Up to 16 weeks.
measure: Changes in the Anosmia score
timeFrame: Up to 16 weeks.
measure: Changes in nasal congestion score (NCS)
timeFrame: Up to 16 weeks.
measure: Changes in nasal/post-nasal discharge scores
timeFrame: Up to 16 weeks.
measure: Changes in facial pain/pressure scores
timeFrame: Up to 16 weeks.
measure: Changes in the Visual analogue Scale (VAS) of sinusitis
timeFrame: Up to 16 weeks.
measure: Subjects' Health-related Quality of Life (HRQoL) questionnaire
timeFrame: Up to 16 weeks.
measure: Changes in nasal peak inspiratory flow rate (NPIF)
timeFrame: Up to 16 weeks.
measure: Systemic glucocorticoid (SCS) remedial or surgical treatment rate
timeFrame: Up to 16 weeks.
measure: Incidence of adverse events
timeFrame: Up to 24 weeks.
measure: Severity of adverse events
timeFrame: Up to 24 weeks.
measure: Peak concentration (Cmax)
timeFrame: 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.
measure: Trough concentration (Cmin)
timeFrame: 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.
measure: Peak time (Tmax)
timeFrame: 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.
measure: Area under blood concentration-time curve (AUC0-t)
timeFrame: 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.
measure: Steady-state peak concentration (Css-max)
timeFrame: 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.
measure: Steady-state valley concentration (Css-min)
timeFrame: 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.
measure: Mean steady-state blood concentration (Css-av)
timeFrame: 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.
measure: Steady-state peak time (Tss-max)
timeFrame: 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.
measure: Area under steady state blood concentration-time curve (AUC ss,0-t)
timeFrame: 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.
measure: Elimination half-life
timeFrame: 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.
measure: Apparent volume of distribution (Vd/F)
timeFrame: 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.
measure: Clearance rate (CL/F)
timeFrame: 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.
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing TongRen Hospital, Capital Medical University
state: Beijing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated hospital of Guizhou Medical University
state: Guizhou
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospitalc, Tongji Medical College, Huazhong, University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Loudi Central Hospital
state: Hunan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Yanji
country: China
facility: The Affiliated Hospital of Yanbian University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Central Hospital of Shenyang Medical College
state: Liaoning
city: Jinan
country: China
facility: Shandong Second People's Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang Second People's Hospital
state: Shandong
city: Weihai
country: China
facility: Weihai Central Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Taizhou
country: China
facility: Wenling First People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou central hospital
state: Zhejiang
Study officials:
References: