A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.
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.
1 other identifier
interventional
160
1 country
36
Brief Summary
To evaluate the effectiveness, safety and pharmacokinetics of TQH2722 injection in patients with chronic sinusitis with or without nasal polyps.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2023
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedStudy Start
First participant enrolled
December 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedJuly 14, 2025
April 1, 2025
1.3 years
October 13, 2023
July 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in nasal polyp score in Part A
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.
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 Outcomes (26)
Changes in sinus CT scan Lund Mackay score in Part A
Up to 16 weeks.
Changes in the Lund-Kennedy score by nasal endoscopy
Up to 16 weeks.
Changes in University of Pennsylvania Smell Identification Test (UPSIT)
Up to 16 weeks.
Changes in Nasal Total Symptom Score (sTSS)
Up to 16 weeks.
Changes in the Anosmia score
Up to 16 weeks.
- +21 more secondary outcomes
Study Arms (3)
300mg of TQH2722 injection
EXPERIMENTALTQH2722 injection, 14 days as a treatment cycle.
600mg of TQH2722 injection
EXPERIMENTALTQH2722 injection, 14 days as a treatment cycle.
TQH2722 injection matching placebo
PLACEBO COMPARATORTQH2722 injection matching placebo, 14 days as a treatment cycle.
Interventions
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
Placebo without active substance.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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);
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000, China
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Beijing TongRen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000, China
Foshan First People's Hospital
Foshan, Guangdong, 528000, China
Jieyang People's Hospital
Jieyang, Guangdong, 522000, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Affiliated hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061000, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Union Hospitalc, Tongji Medical College, Huazhong, University of Science and Technology
Wuhan, Hubei, 430023, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Loudi Central Hospital
Changsha, Hunan, 417000, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014040, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Jilin Province People's Hospital
Changchun, Jilin, 130012, China
The Affiliated Hospital of Yanbian University
Yanji, Jilin, 133002, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Central Hospital of Shenyang Medical College
Shenyang, Liaoning, 110024, China
Shandong Second People's Hospital
Jinan, Shandong, 250022, China
Weifang Second People's Hospital
Weifang, Shandong, 261041, China
Weihai Central Hospital
Weihai, Shandong, 264400, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zibo Central Hospital
Zibo, Shandong, 255036, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30001, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011, China
Wenling First People's Hospital
Taizhou, Zhejiang, 317599, China
Taizhou central hospital
Taizhou, Zhejiang, 318000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2023
First Posted
October 18, 2023
Study Start
December 28, 2023
Primary Completion
March 30, 2025
Study Completion
April 30, 2025
Last Updated
July 14, 2025
Record last verified: 2025-04