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A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third Hospital
  • Beijing Tongren Hospital, CMU
  • Xiangya Hospital Central South University
  • The second Xiangya Hospital of Central South University
  • West China Hospital,Sichuan University
  • The First Affiliated Hospital of Chongqing Medical University
  • The First Hospital Affiliated to AMU (Southwest Hospital)
  • Fujian Medical University
  • Dermatology Hospital of Southern Medical University
  • Zhejiang Provincial People's Hospital
  • The Second Affiliated Hospital of Zhejiang University College of Medicine
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • The 1st affiliated hospital of Anhui Medical University
  • Skin Disease Hospital of Shandong Province
  • Jiangsu Province Hospital
  • Hospital of Dermatology, Chinese Academy of Medical Science
  • Shanghai Ruijin Hospital
  • Huashan Hospital Fudan University
  • Shanghai skin disease hospital
  • University of Hong Kong-Shenzhen Hospital
  • Tianjin Medical University General Hospital
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Henan province people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: Guselkumab

Group 2: Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=)90 percent (%) improvement in PASI score.
Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Number of Participants with Reasonably Related Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Number of Participants with Infections
Number of participants with infections including serious infections, and infections requiring oral or parenteral antimicrobial treatment will be reported.
Number of Participants with Serious Hypersensitivity Reactions
Number of participants with serious hypersensitivity reactions (such as anaphylaxis, urticaria, pruritis, angioedema, wheezing, dyspnea, or hypotension) will be reported.
Number of Participants with Injection-site Reactions
An injection-site reaction is any unfavorable or unintended sign that occurs at the study drug injection site. Injection sites will be evaluated for reactions and any injection-site reaction will be recorded as an AE.
Number of Participants with Change from Baseline in Laboratory Abnormalities
Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported.
Number of Participants with Laboratory Abnormalities with Maximum Toxicity Grades
Number of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades will be reported. A higher grade indicates more severity.
Number of Participants with Change from Baseline in Vital Signs
Number of participants with change from baseline in vital signs (temperature, heart rate, respiratory rate, blood pressure) will be reported.

Secondary Outcome Measures

Percentage of Participants who Achieve a PASI 100, PASI 75, and PASI 50 Response Over Time
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100, 75, and 50 response is defined as 100%, >=75%, and >=50% improvement in PASI score respectively.
Percentage of Participants who Achieve a PASI 90 Response Over Time
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score.
Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time
Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) over time will be reported.
Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.
Percentage of Participants who Maintain PASI 90 Response at Week 48 Among Participants who were PASI 90 Responders at Week 16 in Guselkumab Group
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score.
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
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 will be reported.
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
Percentage of participants who achieve an IGA score of cleared (0) and an IGA score of mild or better (<=2) over time will be reported.
Percentage of Participants who Achieve a DLQI Score of 0 or 1 Over Time Among Participants with Baseline DLQI Greater Than (>) 1
Percentage of participants who achieve a DLQI score of 0 or 1 over time among participants with baseline DLQI >1 will be reported.
Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time
Percentage of participants with a reduction of 5 or more points in DLQI score over time will be reported.
Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Over Time Among Participants with Nail Psoriasis at Baseline
The NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0-4 (A higher score indicates more severity). The sum of these scores is the total NAPSI score (0=no psoriasis to 8=psoriasis present in all 4 quadrants of the target nail).
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
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Serum Concentration of Guselkumab Over Time
Serum concentrations of guselkumab over time will be reported.
Number of Participants with Antibodies to Guselkumab
Number of participants with antibodies to guselkumab through week 56 will be reported.
Maximum Titer of Antibodies to Guselkumab Through Week 56
Maximum titer of antibodies to guselkumab through Week 56 will be reported.

Full Information

First Posted
June 3, 2021
Last Updated
October 11, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04914429
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
September 26, 2023 (Actual)
Study Completion Date
September 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Guselkumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
TREMFYA
Intervention Description
Guselkumab 100 mg will be administered as a SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered as a SC injection.
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Description
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=)90 percent (%) improvement in PASI score.
Time Frame
Week 16
Title
Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Description
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame
Week 16
Title
Number of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to Week 56
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame
Up to Week 56
Title
Number of Participants with Reasonably Related Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to Week 56
Title
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Description
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to Week 56
Title
Number of Participants with Infections
Description
Number of participants with infections including serious infections, and infections requiring oral or parenteral antimicrobial treatment will be reported.
Time Frame
Up to Week 56
Title
Number of Participants with Serious Hypersensitivity Reactions
Description
Number of participants with serious hypersensitivity reactions (such as anaphylaxis, urticaria, pruritis, angioedema, wheezing, dyspnea, or hypotension) will be reported.
Time Frame
Up to Week 56
Title
Number of Participants with Injection-site Reactions
Description
An injection-site reaction is any unfavorable or unintended sign that occurs at the study drug injection site. Injection sites will be evaluated for reactions and any injection-site reaction will be recorded as an AE.
Time Frame
Up to Week 56
Title
Number of Participants with Change from Baseline in Laboratory Abnormalities
Description
Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported.
Time Frame
Up to Week 56
Title
Number of Participants with Laboratory Abnormalities with Maximum Toxicity Grades
Description
Number of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades will be reported. A higher grade indicates more severity.
Time Frame
Up to Week 56
Title
Number of Participants with Change from Baseline in Vital Signs
Description
Number of participants with change from baseline in vital signs (temperature, heart rate, respiratory rate, blood pressure) will be reported.
Time Frame
Up to Week 56
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve a PASI 100, PASI 75, and PASI 50 Response Over Time
Description
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100, 75, and 50 response is defined as 100%, >=75%, and >=50% improvement in PASI score respectively.
Time Frame
Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Title
Percentage of Participants who Achieve a PASI 90 Response Over Time
Description
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score.
Time Frame
Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Title
Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time
Description
Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) over time will be reported.
Time Frame
Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
Description
The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.
Time Frame
Baseline, Week 4, 16, 28, 48
Title
Percentage of Participants who Maintain PASI 90 Response at Week 48 Among Participants who were PASI 90 Responders at Week 16 in Guselkumab Group
Description
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score.
Time Frame
Week 48
Title
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
Description
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 will be reported.
Time Frame
Week 48
Title
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
Description
Percentage of participants who achieve an IGA score of cleared (0) and an IGA score of mild or better (<=2) over time will be reported.
Time Frame
Week 0, 4, 12, 16, 20, 28, 36, 44, 48
Title
Percentage of Participants who Achieve a DLQI Score of 0 or 1 Over Time Among Participants with Baseline DLQI Greater Than (>) 1
Description
Percentage of participants who achieve a DLQI score of 0 or 1 over time among participants with baseline DLQI >1 will be reported.
Time Frame
Week 0, 4, 16, 28, 48
Title
Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time
Description
Percentage of participants with a reduction of 5 or more points in DLQI score over time will be reported.
Time Frame
Week 0, 4, 16, 28, 48
Title
Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Over Time Among Participants with Nail Psoriasis at Baseline
Description
The NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0-4 (A higher score indicates more severity). The sum of these scores is the total NAPSI score (0=no psoriasis to 8=psoriasis present in all 4 quadrants of the target nail).
Time Frame
Baseline, Week 16, 28, 36, 48
Title
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
Description
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Time Frame
Week 0, 16, 28, 36, 48
Title
Serum Concentration of Guselkumab Over Time
Description
Serum concentrations of guselkumab over time will be reported.
Time Frame
Week 0, 4, 16, 20, 36, 44, 56
Title
Number of Participants with Antibodies to Guselkumab
Description
Number of participants with antibodies to guselkumab through week 56 will be reported.
Time Frame
Week 0, 16, 44, 56
Title
Maximum Titer of Antibodies to Guselkumab Through Week 56
Description
Maximum titer of antibodies to guselkumab through Week 56 will be reported.
Time Frame
Week 0, 16, 44, 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Tongren Hospital, CMU
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
The second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
West China Hospital,Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The First Hospital Affiliated to AMU (Southwest Hospital)
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
ZIP/Postal Code
510091
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
ZIP/Postal Code
310004
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University College of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
The 1st affiliated hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
Skin Disease Hospital of Shandong Province
City
Jinan
ZIP/Postal Code
250022
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Hospital of Dermatology, Chinese Academy of Medical Science
City
Nanjing
ZIP/Postal Code
210042
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai skin disease hospital
City
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
University of Hong Kong-Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518053
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
City
Tianjin
ZIP/Postal Code
300120
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
Henan province people's hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

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A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

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