A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female subjects aged 18-75 years (inclusive)
• Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
• Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
• Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator
• Subjects who are able to use effective contraception from the screening period to 6 months after the last dose
Locations
Other Locations
China
Beijing Friendship Hospital
RECRUITING
Beijing
China-Japan Friendship hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
Jilin University Second Hospital
RECRUITING
Changchun
The first hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital of Central South University
RECRUITING
Changsha
Affiliated Hospital of Chengde Medical University
RECRUITING
Chengde
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqing Traditional Chinese Medicine Hospital
NOT_YET_RECRUITING
Chongqing
Dongguan People's Hospital
RECRUITING
Dongguan
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Dermatology Hospital of Southern Medical University
RECRUITING
Guangzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Hangzhou First People's Hospital
RECRUITING
Hangzhou
Hangzhou Third People's Hospital
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Jiangmen Central Hospital
NOT_YET_RECRUITING
Jiangmen
Jiaxing First Hospital
RECRUITING
Jiaxing
Shandong Dermatology Hospital
RECRUITING
Jinan
Jining First People's Hospital
NOT_YET_RECRUITING
Jining
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The Second Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Dermatology Hospital of Jiangxi Province
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu University Affiliated Hospital
RECRUITING
Nanjing
Nanyang First People's Hospital
RECRUITING
Nanyang
Ningbo Second Hospital
RECRUITING
Ningbo
Shanghai Dermatology Hospital
RECRUITING
Shanghai
People's Hospital of Liaoning Province
RECRUITING
Shenyang
Shenzhen People's Hospital
RECRUITING
Shenzhen
Shiyan People's Hospital
RECRUITING
Shiyan
The Second Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Wenzhou Medical University Affiliated First Hospital
RECRUITING
Wenzhou
Wuhan University People's Hospital
RECRUITING
Wuhan
The First Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
Wuxi Second People's Hospital
RECRUITING
Wuxi
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Xingtai People's Hospital
RECRUITING
Xingtai
Yangjiang People's Hospital
NOT_YET_RECRUITING
Yangjiang
Contact Information
Primary
Jianzhong Zhang, MD
rmzjz@126.com
86-10-88326666
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 400
Treatments
Experimental: HB0017
Participants will receive HB0017 at week 0,1,2,4,8 followed by once every four weeks (Q4W) or once every eight weeks (Q8W) at Week 12.
Placebo_comparator: placebo
Participants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.
Related Therapeutic Areas
Sponsors
Leads: Huabo Biopharm Co., Ltd.