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A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Summary
This study is a marketing-oriented clinical trial of TQH3906 Capsules. A total of 156 participants are planned to be enrolled, aiming to evaluate the dose-effect relationship of TQH3906 versus placebo in the treatment of active Psoriatic Arthritis (PsA) at Week 12, with the proportion of participants achieving an American College of Rheumatology 20% (ACR20) Improvement Criteria (ACR20) response at Week 12 as the primary endpoint.
Official title: A Randomized, Placebo- and Active Drug-Controlled, Double-Blind, Multicenter, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2026-04
Completion Date
2027-11
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
TQH3906 Capsule
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
TQH3906 Placebo Capsule
Placebo without drug substance.
Tofacitinib Citrate Tablet 5 mg
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.
Locations (43)
Bozhou People's Hospital
Bozhou, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Bao Ding NO.1 Central
Baoding, Hebei, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
Cangzhou, Hebei, China
Kaifeng People's Hospital
Kaifeng, Henan, China
Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital)
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Central Hospital of Shaoyang
Shaoyang, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Jiangsu Peopince Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Yancheng No.1 People's Hospital
Yancheng, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Jilin Provincial People's Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The second hospital of dalian medical university
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
Weifang People'S Hospital
Weifang, Shandong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
Deyang People's Hospital
Deyang, Sichuan, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo Medical Center Li HuiLi Hospital
Ningbo, Zhejiang, China