Treatment of chronic sinusitis with TQH2722 injection

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.

This study is testing a new injection called TQH2722 to see if it can help adults with chronic sinusitis feel better, whether or not they have nasal polyps.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 36 sites (Wuhu, Anhui and 35 other locations)
• Trial ID: NCT06089278 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness, safety, and pharmacokinetics of TQH2722 injection in patients suffering from chronic sinusitis, with or without nasal polyps. Participants will receive either a 300mg or 600mg dose of the injection, or a matching placebo, to determine the optimal treatment approach. The study aims to recruit individuals aged 18-75 who have been diagnosed with bilateral chronic sinusitis and have a history of corticosteroid use. The research will follow strict eligibility criteria to ensure the safety and relevance of the findings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with chronic sinusitis who have not responded adequately to previous corticosteroid treatments.

Not a fit: Patients with acute sinusitis or those who have not been diagnosed with chronic sinusitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chronic sinusitis, potentially improving their quality of life.

How similar studies have performed: While there is ongoing research in the treatment of chronic sinusitis, the specific use of TQH2722 injection represents a novel approach that has not been widely tested.

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.

Where this trial is running

Wuhu, Anhui and 35 other locations

• The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Not_yet_recruiting)
• Beijing Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Beijing TongRen Hospital, Capital Medical University — Beijing, Beijing, China (Not_yet_recruiting)
• Lanzhou University Second Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• Foshan First People's Hospital — Foshan, Guangdong, China (Not_yet_recruiting)
• Jieyang People's Hospital — Jieyang, Guangdong, China (Not_yet_recruiting)
• The Second People's Hospital of Shenzhen — Shenzhen, Guangdong, China (Not_yet_recruiting)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Not_yet_recruiting)
• The Affiliated hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• Hebei Medical University Third Hospital — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospitalc, Tongji Medical College, Huazhong, University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• Loudi Central Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Baotou Central Hospital — Baotou, Inner Mongolia, China (Not_yet_recruiting)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Jilin Province People's Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The Affiliated Hospital of Yanbian University — Yanji, Jilin, China (Not_yet_recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Central Hospital of Shenyang Medical College — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shandong Second People's Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Weifang Second People's Hospital — Weifang, Shandong, China (Not_yet_recruiting)
• Weihai Central Hospital — Weihai, Shandong, China (Not_yet_recruiting)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (Not_yet_recruiting)
• Zibo Central Hospital — Zibo, Shandong, China (Not_yet_recruiting)
• Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Not_yet_recruiting)
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Chengdu Second People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Urumqi, Xinjiang, China (Not_yet_recruiting)
• Wenling First People's Hospital — Taizhou, Zhejiang, China (Not_yet_recruiting)
• Taizhou central hospital — Taizhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Luo Zhang, Doctor

Conditions Sinusitis