A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT04914429
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
327 participants
INTERVENTIONAL
2021-08-25
2023-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Guselkumab
Guselkumab 100 mg will be administered as a SC injection.
Placebo
Matching placebo will be administered as a SC injection.
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.
Guselkumab
Guselkumab 100 mg will be administered as a SC injection.
Placebo
Matching placebo will be administered as a SC injection.
Interventions
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Guselkumab
Guselkumab 100 mg will be administered as a SC injection.
Placebo
Matching placebo will be administered as a SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Has a history of or current signs or symptoms of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter/minute \[mL/min\]); significant, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Currently has a or has a history of malignancy within 5 year before screening (exceptions are nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration and cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before screening, or malignancy, which is considered cured with minimal risk of recurrence)
* History of, or ongoing, chronic or recurrent infectious disease, including but not limited to, recurrent sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infection (example, recurrent pyelonephritis, recurrent cystitis), fungal infection (mucocutaneous candidiasis), an open, draining, or infected skin wound, or an ulcer
* Has previously received guselkumab
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Peking University Third Hospital
Beijing, , China
Beijing Tongren Hospital, CMU
Beijing, , China
Xiangya Hospital Central South University
Changsha, , China
The second Xiangya Hospital of Central South University
Changsha, , China
West China Hospital,Sichuan University
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, , China
Fujian Medical University
Fuzhou, , China
Dermatology Hospital of Southern Medical University
Guangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, , China
The 1st affiliated hospital of Anhui Medical University
Hefei, , China
Skin Disease Hospital of Shandong Province
Jinan, , China
Jiangsu Province Hospital
Nanjing, , China
Hospital of Dermatology, Chinese Academy of Medical Science
Nanjing, , China
Shanghai Ruijin Hospital
Shanghai, , China
Huashan Hospital Fudan University
Shanghai, , China
Shanghai skin disease hospital
Shanghai, , China
University of Hong Kong-Shenzhen Hospital
Shenzhen, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Henan province people's hospital
Zhengzhou, , China
Countries
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References
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Huang K, Geng S, Tao X, Sun L, Ji C, Yang B, Lu Y, Xiao R, Zhang C, Zhang F, Lu Q, Zheng J, Wang H, Shi Y, Li Z, Yan W, Zhang L, Tao J, Zhang S, Yang X, Cheng H, Xu J, Su J, Zhang Z, Song Z, Wang L, Wang R, Zhang T, Zhao W, Huang Y, Chen M, Dong Z, Lyu S, Zheng M. Efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled trial. Chin Med J (Engl). 2025 Sep 8. doi: 10.1097/CM9.0000000000003771. Online ahead of print.
Other Identifiers
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CNTO1959PSO4009
Identifier Type: OTHER
Identifier Source: secondary_id
CR109025
Identifier Type: -
Identifier Source: org_study_id
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