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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 26
- 主要终点
- Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Guselkumab (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: Guselkumab (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Up to Week 56
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Number of Participants with Infections
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to Week 56
Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported.
次要结局
- 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)
- 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 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 a PASI 100, PASI 75, and PASI 50 Response Over Time(Week 0, 4, 12, 16, 20, 28, 36, 44, 48)
- Percentage of Participants who Achieve a PASI 90 Response 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(Week 0, 4, 12, 16, 20, 28, 36, 44, 48)
- Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time(Baseline, Week 4, 16, 28, 48)
- 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 With a Reduction of 5 or More Points in DLQI Score Over Time(Week 0, 4, 16, 28, 48)
- 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)
- 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)
- Serum Concentration of Guselkumab Over Time(Week 0, 4, 16, 20, 36, 44, 56)
- Number of Participants with Antibodies to Guselkumab(Week 0, 16, 44, 56)
- Maximum Titer of Antibodies to Guselkumab Through Week 56(Week 0, 16, 44, 56)