A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis
Who is this study for? Patients with Psoriasis
What treatments are being studied? Guselkumab
Status: Completed
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in the treatment of Chinese participants with moderate to severe plaque psoriasis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have a diagnosis of plaque psoriasis with or without psoriatic arthritis for at least 6 months before screening
• A woman of childbearing potential must have a negative urine pregnancy test at screening and at baseline
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
• Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet (UV) light sources during study
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Locations
Other Locations
China
Beijing Tongren Hospital, CMU
Beijing
Peking University Third Hospital
Beijing
The second Xiangya Hospital of Central South University
Changsha
Xiangya Hospital Central South University
Changsha
West China Hospital,Sichuan University
Chengdu
The First Affiliated Hospital of Chongqing Medical University
Chongqing
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing
Fujian Medical University
Fuzhou
Dermatology Hospital of Southern Medical University
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
The 1st affiliated hospital of Anhui Medical University
Hefei
Skin Disease Hospital of Shandong Province
Jinan
Hospital of Dermatology, Chinese Academy of Medical Science
Nanjing
Jiangsu Province Hospital
Nanjing
Huashan Hospital Fudan University
Shanghai
Shanghai Ruijin Hospital
Shanghai
Shanghai skin disease hospital
Shanghai
University of Hong Kong-Shenzhen Hospital
Shenzhen
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin
Tianjin Medical University General Hospital
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Henan province people's hospital
Zhengzhou
Time Frame
Start Date:2021-08-25
Completion Date:2023-09-26
Participants
Target number of participants:327
Treatments
Experimental: Group 1: Guselkumab
Participants will receive guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, and then every 8 weeks (q8w) through Week 44. Participants will receive matching placebo at Week 16.
Placebo_comparator: Group 2: Placebo
Participants will receive placebo SC injection for guselkumab at Weeks 0, 4, and 12, and then cross over at Week 16 to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and q8w thereafter through Week 44.