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NOT YET RECRUITING
NCT07406035
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

TQH3906 Capsule

TQH3906 is a small-molecule inhibitor of tyrosine kinase.

DRUG

TQH3906 Placebo Capsule

Placebo without drug substance.

DRUG

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