A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT04914429
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 327
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Guselkumab Placebo 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. Group 2: Placebo 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. Group 1: Guselkumab 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. Group 2: Placebo Guselkumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 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 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) Up to Week 56 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) Up to Week 56 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) Up to Week 56 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 Up to Week 56 Number of participants with AEs leading to discontinuation of study intervention will be reported.
Number of Participants with Infections Up to Week 56 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 Up to Week 56 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 Up to Week 56 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 Laboratory Abnormalities with Maximum Toxicity Grades Up to Week 56 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 Up to Week 56 Number of participants with change from baseline in vital signs (temperature, heart rate, respiratory rate, blood pressure) will be reported.
Number of Participants with Change from Baseline in Laboratory Abnormalities Up to Week 56 Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Maintain PASI 90 Response at Week 48 Among Participants who were PASI 90 Responders at Week 16 in Guselkumab Group Week 48 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 Week 48 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 Week 0, 4, 12, 16, 20, 28, 36, 44, 48 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 PASI 100, PASI 75, and PASI 50 Response Over Time Week 0, 4, 12, 16, 20, 28, 36, 44, 48 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 Week 0, 4, 12, 16, 20, 28, 36, 44, 48 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 Week 0, 4, 12, 16, 20, 28, 36, 44, 48 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 Baseline, Week 4, 16, 28, 48 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 Achieve a DLQI Score of 0 or 1 Over Time Among Participants with Baseline DLQI Greater Than (>) 1 Week 0, 4, 16, 28, 48 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 Week 0, 4, 16, 28, 48 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 Baseline, Week 16, 28, 36, 48 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 Week 0, 16, 28, 36, 48 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 Week 0, 4, 16, 20, 36, 44, 56 Serum concentrations of guselkumab over time will be reported.
Number of Participants with Antibodies to Guselkumab Week 0, 16, 44, 56 Number of participants with antibodies to guselkumab through week 56 will be reported.
Maximum Titer of Antibodies to Guselkumab Through Week 56 Week 0, 16, 44, 56 Maximum titer of antibodies to guselkumab through Week 56 will be reported.
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Trial Locations
- Locations (26)
Beijing Tongren Hospital, CMU
🇨🇳Beijing, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
Shanghai Ruijin 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
Fujian Medical University
🇨🇳Fuzhou, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
🇨🇳Hangzhou, China
Henan province people's hospital
🇨🇳Zhengzhou, China
West China Hospital,Sichuan University
🇨🇳Chengdu, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, China
The 1st affiliated hospital of Anhui Medical University
🇨🇳Hefei, China
Huashan Hospital Fudan University
🇨🇳Shanghai, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Peking University Third Hospital
🇨🇳Beijing, China
The second Xiangya Hospital of Central South University
🇨🇳Changsha, China
The First Hospital Affiliated to AMU (Southwest Hospital)
🇨🇳Chongqing, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Skin Disease Hospital of Shandong Province
🇨🇳Jinan, China
Hospital of Dermatology, Chinese Academy of Medical Science
🇨🇳Nanjing, China
Shanghai skin disease hospital
🇨🇳Shanghai, China
Jiangsu Province Hospital
🇨🇳Nanjing, China