A Phase II Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamic (PD) Profile of TQH3906 in Subjects With Moderate to Severe Plaque Psoriasis

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Be 18-70 years old (both 18 and 70 years old), regardless of gender;

• Clinically diagnosed with stable moderate to severe plaque psoriasis with a history ≥ 6 months (from randomization), and no morphological changes in skin lesions or significant disease outbreaks as assessed by the investigator;

• Appropriate for systemic therapy or phototherapy as judged by the investigator;

• At screening and baseline, the PASI score was ≥ 12 points, the BSA ≥ 10%, and the sPGA ≥ 3 points ;

• Have a full understanding of this study, voluntarily participate in the trial, and have signed a written informed consent form;

• Subjects (including partners) are willing to voluntarily use appropriate and effective contraceptive measures from screening to 3 months after the last dose of study drug.

Locations
Other Locations
China
The First Affiliated Hospital of Baotou Medical College
NOT_YET_RECRUITING
Baotou
Beijing Tongren Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
The First Bethune Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The First People's Hospital of Changde
NOT_YET_RECRUITING
Changde
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
The first affiliated hospital of chongqing medical university
NOT_YET_RECRUITING
Chongqing
Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Affiliated Hangzhou First People'S Hospital,School of Medicine, Westlake University
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang University School Of Medicine
NOT_YET_RECRUITING
Hangzhou
Heilongjiang Provincial Hospital
NOT_YET_RECRUITING
Harbin
Shandong First Medical University Affiliated Dermatology Hospital
NOT_YET_RECRUITING
Jinan
Shandong University Qilu Hospital
NOT_YET_RECRUITING
Jinan
Liuzhou People'S Hospital
NOT_YET_RECRUITING
Liuzhou
The Second Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
Meihekou Central Hospital
NOT_YET_RECRUITING
Meihekou
Hospital of Dermatology, Chinese Academy of Medical Sciences
RECRUITING
Nanjing
Nanyang First People'S Hospital
NOT_YET_RECRUITING
Nanyang
Genertec Liaoyou Gem Flower Hospital
NOT_YET_RECRUITING
Panjin
Qingdao Municipal hospital (group)
NOT_YET_RECRUITING
Qingdao
Qingdao Traditional Chinese Medicine Hospital
RECRUITING
Qingdao
Shanghai JiaoTong University of medicine Ruijin Hospital
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The first hospital of china medical university
NOT_YET_RECRUITING
Shenyang
Shijiazhuang Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Shijiazhuang
The Second Hospital of HeBei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shiyan Renmin Hospital
NOT_YET_RECRUITING
Shiyan
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Shanxi Provincial People's Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
NOT_YET_RECRUITING
Tianjin
Xinjiang Uygur Autonomous Region People's Hospital
NOT_YET_RECRUITING
Ürümqi
Wuhan First Hospital
NOT_YET_RECRUITING
Wuhan
The Second Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The Second Affiliated Hospital Of Xingtai Medical Colledge
NOT_YET_RECRUITING
Xingtai
Yancheng First People's Hospital
NOT_YET_RECRUITING
Yancheng
Contact Information
Primary
Xinghua Gao, Doctor
gaobarry@hotmail.com
13940152467
Time Frame
Start Date: 2024-08-27
Estimated Completion Date: 2026-09
Participants
Target number of participants: 210
Treatments
Experimental: TQH3906 capsules
TQH3906 capsules are administered orally at the same time (±2 hours) on an empty stomach every day for 12 weeks starting from Day 1.
Placebo_comparator: Placebo of TQH3906 capsules
TQH3906 capsules placebo: TQH3906 capsules placebo administered orally once daily for 12 weeks at the same time (±2 hours) on an empty stomach starting from Day 1.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov