A Multicenter, Randomized, Ongoing Trial Evaluating the Long-term Safety and Efficacy of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study aims to evaluate the efficacy and safety of TQC2731 injection in the treatment of chronic sinusitis with nasal polyps.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects sign informed consent before study, fully understand the purpose, procedures and possible adverse reactions of the study;
• Male and female, ≥18 years old;
• Participate in the clinical study of TQC2731 for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) (study number TQC2731-II-02) and meet the following criteria a or b: a. Participants complete the prescribed treatment according to the protocol requirements and complete end of treatment (EOT) visits; b. The subject withdrew early due to poor compliance or other objective reasons other than TQC2731 related adverse events (AEs), and completed the early withdrawal visit according to the plan. After evaluation by the researcher and sponsor, the factors that led to the subject's early termination of the main study treatment have disappeared/no longer affect the subject's participation in this continuing study;
• Subjects used steady dose of intranasal glucocorticoids (INCS) over 4 weeks before screening (subjects willing to use Mometasone Furoate Aqueous Nasal Spray (MFNS) while studying);
• Subjects agree from sign informed consent to last administration over 6 mouth without Family planning,and take effective non-pharmaceutical contraception.
Locations
Other Locations
China
Cangzhou Central Hospital
NOT_YET_RECRUITING
Cangzhou
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
ChengDu Second People's Hospital
NOT_YET_RECRUITING
Chengdu
Hospital of Chengdu University of TCM
NOT_YET_RECRUITING
Chengdu
West China Hospital
NOT_YET_RECRUITING
Chengdu
Affiliated Zhongshan Hospital Of Dalian university
NOT_YET_RECRUITING
Dalian
ZhuJiang Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Afiliated Hospital Of QINGDAO University
NOT_YET_RECRUITING
Qingdao
Eye&Ent Hospital of Fudan University
RECRUITING
Shanghai
Pudong New area Gongli Hospital Shanghai
NOT_YET_RECRUITING
Shanghai
Tianjin People's Hospital
NOT_YET_RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
The First Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
The Fifth Affiliated Hospital Sun Yat-Sen University
NOT_YET_RECRUITING
Zhuhai
Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Dehui Wang, Doctor
wangdehuient@sina.com
13701852008
Time Frame
Start Date:2024-07-04
Estimated Completion Date:2026-02
Participants
Target number of participants:60
Treatments
Experimental: 210mg of TQC2731 injection
210mg of TQC2731 injection combined with Mometasone Furoate Aqueous Nasal Spray, 28days as a treatment cycle.
Experimental: 420mg of TQC2731 injection
420mg of TQC2731 injection combined with Mometasone Furoate Aqueous Nasal Spray, 28days as a treatment cycle.