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A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque Psoriasis
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Summary
This study is a multicenter, randomized, double-blind, placebo- and active-controlled Phase III clinical trial sponsored by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of Chiatai Tianqing Pharmaceutical Group. The study aims to evaluate the efficacy and safety of once-daily oral TQH3906 capsules (24 mg) in adult participants with moderate to severe plaque psoriasis. TQH3906 is a highly selective TYK2 allosteric inhibitor targeting the JH2 domain, which blocks the IL-23 and Type I interferon inflammatory pathways. Approximately 400 eligible participants aged 18-75 years will be enrolled. Participants will be stratified based on prior biologic use and randomized in a 2:2:1 ratio to the TQH3906 group, the deucravacitinib active control group, or the placebo group. The trial includes a screening period, a 16-week double-blind controlled treatment phase, a 36-week open-label extension phase (during which all participants will receive TQH3906), and a 4-week safety follow-up after the last dose. The co-primary endpoints are the proportion of participants achieving sPGA 0/1 and PASI 90 response at Week 16. Secondary endpoints include improvements in scalp, nail, and palmoplantar psoriasis, Dermatology Life Quality Index (DLQI), long-term safety, and steady-state pharmacokinetic parameters. This study will collect comprehensive efficacy and safety data over 52 weeks to support the New Drug Application (NDA) for TQH3906 for the treatment of plaque psoriasis.
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Adult Patients With Moderate to Severe Plaque Psoriasis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-09-02
Completion Date
2028-06
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
TQH3906 capsules
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
Deucravacitinib tablets 6 mg
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
TQH3906 Capsules placebo
No pharmacologically active substance
Deucravacitinib tablets placebo
No pharmacologically active substance
Locations (45)
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University 。
Chongqing, Chongqing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Hainan Fifth People's Hospital
Haikou, Hainan, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Shijiazhuang Traditional Chinese Medicine Hospital
Shijiazhuang, Hebei, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Henan University of science and technology
Luoyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
The First Peopel's Hospital of Zhengzhou
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Chinese Academy of Medical Sciences Hospital for Skin Diseases
Nanjing, Jiangsu, China
Nantong Cancer Hospital
Nantong, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Zhongyi Northeast International Hospital Co., Ltd.
Shengyang, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine, Shenyang Dermatology Hospital)
Shenyang, Liaoning, China
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, China
The First People's Hospital of Xining
Xining, Qinghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Qilu Hospital Dezhou Branch of Shandong University (Dezhou People's Hospital)
Dezhou, Shandong, China
Jining No.1 People'S Hospital
Jining, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
The Second People's Hospital of ChangZhi
Changzhi, Shanxi, China
Suining Central Hospital
Suining, Sichuan, China
Gerneral Hospital of Ningxia Medical Univercity
Yinchuan, The Ningxia Hui Autonomous Region, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China