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RECRUITING
NCT07724366
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

TQH3906 capsules

TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).

DRUG

Deucravacitinib tablets 6 mg

Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).

DRUG

TQH3906 Capsules placebo

No pharmacologically active substance

DRUG

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