Clinical trial NCT04914429: A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
* 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

Primary outcomes:
measure: Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Week 56
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 56
measure: Number of Participants with Reasonably Related Adverse Events (AEs)
timeFrame: Up to Week 56
measure: Number of Participants with AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to Week 56
measure: Number of Participants with Infections
timeFrame: Up to Week 56
measure: Number of Participants with Serious Hypersensitivity Reactions
timeFrame: Up to Week 56
measure: Number of Participants with Injection-site Reactions
timeFrame: Up to Week 56
measure: Number of Participants with Change from Baseline in Laboratory Abnormalities
timeFrame: Up to Week 56
measure: Number of Participants with Laboratory Abnormalities with Maximum Toxicity Grades
timeFrame: Up to Week 56
measure: Number of Participants with Change from Baseline in Vital Signs
timeFrame: Up to Week 56
Secondary outcomes:
measure: Percentage of Participants who Achieve a PASI 100, PASI 75, and PASI 50 Response Over Time
timeFrame: Week 0, 4, 12, 16, 20, 28, 36, 44, 48
measure: Percentage of Participants who Achieve a PASI 90 Response Over Time
timeFrame: Week 0, 4, 12, 16, 20, 28, 36, 44, 48
measure: Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time
timeFrame: Week 0, 4, 12, 16, 20, 28, 36, 44, 48
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
timeFrame: Baseline, Week 4, 16, 28, 48
measure: Percentage of Participants who Maintain PASI 90 Response at Week 48 Among Participants who were PASI 90 Responders at Week 16 in Guselkumab Group
timeFrame: Week 48
measure: Percentage of Participants who Maintain IGA Score of Cleared (0) or Minimal (1) at Week 48 Among Participants who Achieved IGA 0/1 at Week 16 in Guselkumab Group
timeFrame: Week 48
measure: Percentage of Participants who Achieve an IGA Score of Cleared (0) and an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) Over Time
timeFrame: Week 0, 4, 12, 16, 20, 28, 36, 44, 48
measure: Percentage of Participants who Achieve a DLQI Score of 0 or 1 Over Time Among Participants with Baseline DLQI Greater Than (>) 1
timeFrame: Week 0, 4, 16, 28, 48
measure: Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time
timeFrame: Week 0, 4, 16, 28, 48
measure: Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Over Time Among Participants with Nail Psoriasis at Baseline
timeFrame: Baseline, Week 16, 28, 36, 48
measure: Percentage of Participants with an Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) Over Time Among Participants with Scalp Psoriasis and an ss-IGA Score >=2 at Baseline
timeFrame: Week 0, 16, 28, 36, 48
measure: Serum Concentration of Guselkumab Over Time
timeFrame: Week 0, 4, 16, 20, 36, 44, 56
measure: Number of Participants with Antibodies to Guselkumab
timeFrame: Week 0, 16, 44, 56
measure: Maximum Titer of Antibodies to Guselkumab Through Week 56
timeFrame: Week 0, 16, 44, 56
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital, CMU
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Chongqing
country: China
facility: The First Hospital Affiliated to AMU (Southwest Hospital)
city: Fuzhou
country: China
facility: Fujian Medical University
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
city: Hefei
country: China
facility: The 1st affiliated hospital of Anhui Medical University
city: Jinan
country: China
facility: Skin Disease Hospital of Shandong Province
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Hospital of Dermatology, Chinese Academy of Medical Science
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai skin disease hospital
city: Shenzhen
country: China
facility: University of Hong Kong-Shenzhen Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: Henan province people's hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: