A Multicenter, Randomized, Continuing Trial to Evaluate the Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multicenter, randomized, continuing, Phase II expansion trial to evaluate the safety, efficacy, and immunogenicity of two doses of TQH2722 in the long-term treatment of severe chronic sinusitis with or without nasal polyps.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ Inclusion Criteria of Part A

∙ Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;

‣ Age 18-75 years old (including the threshold), male or female;

‣ Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria a or b :

⁃ Subjects completed prescribed treatment as required and completed Part A end of study (EOS) visit;

• The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors.

⁃ Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study.

‣ Subjects had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for subjects who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS), subjects were willing to switch to MFNS during the study);

‣ Subjects agree not to have a family plan for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age.

⁃ Inclusion Criteria of Part B

∙ Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;

‣ Age 18-75 years old (including the threshold), male or female;

‣ Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria a or b :

⁃ Subjects completed prescribed treatment as required and completed Part B EOS visit;

• The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors.

‣ Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study.

• Subjects had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for subjects who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS), subjects were willing to switch to MFNS during the study);

• Subjects agree not to have a family plan for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age.

Locations
Other Locations
China
Baotou Central Hospital
NOT_YET_RECRUITING
Baotou
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
Cangzhou Central Hospital
NOT_YET_RECRUITING
Cangzhou
Jilin Provincial People's Hospital
NOT_YET_RECRUITING
Changchun
Loudi Central Hospital
NOT_YET_RECRUITING
Changsha
Chengdu Second People's Hospital
NOT_YET_RECRUITING
Chengdu
The First People's Hospital of Foshan
NOT_YET_RECRUITING
Foshan
Shandong Second People's Hospital
NOT_YET_RECRUITING
Jinan
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Renji Hospital Shanghai Jiaotong University School of Medical
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital Affiliated to China Medical University
NOT_YET_RECRUITING
Shenyang
The Central Hospital of Shenyang Medical College
NOT_YET_RECRUITING
Shenyang
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Second People's Hospital of Shenzhen
NOT_YET_RECRUITING
Shenzhen
Hebei Medical University Third Hospital
NOT_YET_RECRUITING
Shijiazhuang
First Hospital of Shangxi Medical University
NOT_YET_RECRUITING
Taiyuan
Taizhou central hospital(Taizhou university hospital)
NOT_YET_RECRUITING
Taizhou
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Weihai Central Hospital
NOT_YET_RECRUITING
Weihai
Wenling First People's Hospital
NOT_YET_RECRUITING
Wenling
Renmin Hospital of Wuhan University Hubei General Hospital
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of science and technology
NOT_YET_RECRUITING
Wuhan
The Affiliated Hospital of Yanbian University
NOT_YET_RECRUITING
Yanji
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Zibo Central Hospital
NOT_YET_RECRUITING
Zibo
Zibo Central Hospital
NOT_YET_RECRUITING
Zibo
Contact Information
Primary
Luo Zhang, Postdoctoral
dr.luozhang@139.com
13910830399
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2025-11
Participants
Target number of participants: 120
Treatments
Experimental: 300mg/600mg of TQH2722 injection in Part A or B
For Part A or Part B, 300mg/600mg of TQH2722 injection was administered every 2 weeks until week 22, combined with Mometasone furoate nasal spray of 100-200μg/ day until week 32.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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