An Open-label, Parallel Group, Multicenter Study Evaluating the Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 86
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, tolerability and drug survival of guselkumab in high-dose and extended-interval versus standard-dose in Chinese participants with moderate to severe plaque psoriasis.
详细描述
The study consists of Screening Phase (4 weeks before administration of study drug), Active Treatment Phase (Week 0-Week 86), Follow-up Phase (Week 86-Week 98). During various study periods, safety assessments (example [e.g] recording of adverse events, Vital signs, Tuberculosis evaluation, Chest radiograph, Urine pregnancy test); Efficacy assessments (e.g PASI, IGA, ss-IGA, NAPSI, DLQI); Clinical laboratory assessments (e.g hematology, chemistry); Biomarkers/Genetic evaluations, will be performed per the study procedures. The primary hypotheses are that guselkumab treatment with high-dose and extended-interval is non-inferior to standard dose as assessed by proportion of participants achieving PASI 90 and IGA 0/1 response at Week 86 with noninferiority margin of 13%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Has a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis] PsA) for at least 6 months before the first administration of study drug.
- •Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score >=3, or Investigator's Global Assessment (IGA) >=3, or Affected Body Surface Area (BSA) >= 10% at baseline (Week 0).
- •Be suitable for receiving systemic treatment of psoriasis, as whether biologic-naïve or biologic-experienced participant.
- •A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections.
- •Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination.
- •Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug.
- •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.
- •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).
- •Currently has drug-induced psoriasis (e.g., newly developed psoriasis or exacerbation of psoriasis due to treatment with β-blockers, calcium channel blockers, or lithium).
- •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 years 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).
- •Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
- •Has a 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), or open, draining, or infected skin wounds or ulcers.
- •Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline.
研究组 & 干预措施
Guselkumab in high-dose and extended-interval
Participants will receive 2 injections of active guselkumab as 200 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 8, 20, 36, 56, and 76.
干预措施: Guselkumab (Drug)
Guselkumab in standard-dose
Participants will receive 1 injection of active guselkumab 100 mg SC at Weeks 0, 4, 12, and q8w thereafter through Week 86.
干预措施: Guselkumab (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 86
时间窗: Week 86
The PASI is a system used for assessing and grading the severity of psoriatic lesions. 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 the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Percentage of Participants Who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 86
时间窗: Week 86
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 (AE)
时间窗: Up to Week 98
An AE is any untoward medical occurrence in a participant during a clinical study that does not have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Change from Baseline in Laboratory Abnormalities
时间窗: Up to Week 98
Number of participants with change from baseline in laboratory abnormalities (chemistry, hematology) will be reported.
Number of Participants with Abnormalities of Electrocardiogram (ECG)
时间窗: Up to Week 98
Number of participants with abnormalities of electrocardiogram will be reported.
Number of Participants with Change from Baseline in Vital Signs
时间窗: Up to Week 98
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 Physical Examination
时间窗: Up to Week 98
Number of participants with change from baseline in physical examination will be reported.
Number of Participants with Change from Baseline in Concomitant Medications
时间窗: Up to Week 98
Number of participants with change from baseline in concomitant medications will be reported.
Number of Patients with Injection-site Reactions
时间窗: Up to Week 98
An injection-site reaction is any favorable or unintended sigh 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 Patients with Allergic Reactions
时间窗: Up to Week 98
Number of participants with allergic reactions (skin symptoms such as urticaria, erythema, and itching; respiratory symptoms such as dyspnea, wheezing; gastrointestinal symptoms such as nausea, vomiting, and abdominal pain; and severe allergic symptoms including angioedema, sudden drop of blood pressure, or even anaphylactic shock) will be reported.
Number of Participants with Infections
时间窗: Up to Week 98
Number of participants with infections including serious infections, and infections requiring oral or parenteral antimicrobial treatment will be reported.
次要结局
- Percentages participants who Achieve a PASI 100, PASI 75, and PASI 50 Response at Week 86 and Over Time(Week 12, 20, 52 and 86)
- Percentage of Participants who Achieve a PASI 90 Response Over Time(Week 12, 20, 52 and 86)
- Percentage of Participants who Achieve an IGA Score of Cleared (0) or Minimal (1) Over Time(Week 12, 20, 52 and 86)
- Change from Baseline in Dermatology Life Quality Index (DLQI) Score Over Time(Week 12, 20, 52 and 86)
- Percentage of Participants who Maintain PASI 90 Responders at Week 86 Among Participants who were PASI 90 Responders at Week 48(Week 86)
- Percentage of Participants who Maintain IGA Score of Cleared (0) or Minimal (1) at Week 86 Among Participants who Achieved IGA 0/1 at Week 48(Week 86)
- 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) at Week 86 and Over Time(Week 12, 20, 52 and 86)
- Percentage of Participants who Achieve a DLQI Score of 0 or 1 Over Time Among Participants with Baseline DLQI Greater Than (>) 1(Week 12, 20, 52 and 86)
- Percentage of Participants with a Reduction of 5 or More Points in DLQI Score Over Time(Week 12, 20, 52 and 86)
- Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 36 and Over Time Among Participants with Nail Psoriasis at Baseline(Week 12, 20, 36, 52 and 86)
- Percentage of Participants with a 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 12, 20, 36, 52 and 86)
- Percentage of Participants who Maintain PASI value ≤0.9 at Week 52 Among Participants who had achieved at Week 20(Week 12, 20, 52 and 86)