CNTO1959PSO3018: A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Skin of Color Who Have Moderate-to-Severe Plaque Psoriasis and/or Moderate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 184
- 主要终点
- Cohort A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of 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 [PsA]) for at least 6 months before the first administration of study drug
- •Self-identify as non-white or non-caucasian
- •Be a candidate for phototherapy or systemic treatment for psoriasis
- •Have an involved body surface area (BSA) greater than or equal to (>=) 10 percent (%), psoriasis area and severity index (PASI) >=12, investigator global assessment (IGA) >=3 at screening and at baseline (Cohort A), or have a scalp surface area >=30%, psoriasis scalp severity index (PSSI) >=12, scalp specific investigator global assessment (ss-IGA) >=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
- •Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
- •Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention
排除标准
- •Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
- •Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
- •Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
- •Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening
研究组 & 干预措施
Cohort A: Moderate-to-severe Plaque Psoriasis
Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
干预措施: Placebo (Drug)
Cohort B: Moderate-to-severe Scalp Psoriasis
Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
干预措施: Placebo (Drug)
Cohort B: Moderate-to-severe Scalp Psoriasis
Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
干预措施: Guselkumab (Drug)
Cohort A: Moderate-to-severe Plaque Psoriasis
Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
干预措施: Guselkumab (Drug)
结局指标
主要结局
Cohort A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
时间窗: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (\>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.
Cohort A: Percentage of Participants Who Achieved Psoriasis Area Severity Index (PASI) 90 Response at Week 16
时间窗: Week 16
Percentage of participants who achieved PASI 90 response (greater than or equal to \[\>=\] 90 percent \[%\] improvement from baseline in PASI) at Week 16 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.
Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16
时间窗: Week 16
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease.
Cohort B: Percentage of Participants Who Achieved Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16
时间窗: Week 16
PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (\<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.
次要结局
- Cohort A: Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16(Week 16)
- Cohort A: Percentage of Participants Who Achieved PASI 100 Response at Week 16(Week 16)
- Cohort A: Percent Change From Baseline in PASI Total Score at Week 16(Baseline (Week 0), Week 16)
- Cohort A: Percent Change From Baseline in Body Surface Area (BSA) at Week 16(Baseline (Week 0), Week 16)
- Cohort A: Time to Greater Than or Equal to (>=) 90 Percent (%) Reduction in PASI Score(From baseline (Week 0) up to Week 16)
- Cohorts A and B: Change From Baseline in Total Dermatology Life Quality Index (DLQI) Score at Week 16(Baseline (Week 0), Week 16)
- Cohort A: Percentage of Participants Who Achieved >= 4-point Reduction From Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16 Among Participants With Baseline PSSD Itch Score >=4(Week 16)
- Cohorts A and B: Change From Baseline in PSSD Symptom Score at Week 16(Baseline (Week 0), Week 16)
- Cohorts A and B: Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With Baseline PSSD Symptom Score >=1(Week 16)
- Cohort B: Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score at Week 16(Baseline (Week 0), Week 16)
- Cohort B: Percent Change From Baseline in Scalp Surface Area (SSA) at Week 16(Baseline (Week 0), Week 16)
- Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) at Week 16(Week 16)
- Cohort B: Percentage of Participants Who Achieved PSSI 100 Response at Week 16(Week 16)
- Cohort B: Time to >=90% Reduction in PSSI Score(From Baseline (Week 0) up to Week 16)
- Cohort B: Percentage of Participants Who Achieved >=4-point Reduction From Baseline in the Scalp Itch Numeric Rating Scale (NRS) Score at Week 16 Among Participants With Baseline Scalp Itch Score >=4(Week 16)
- Cohorts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112)
- Cohorts A and B: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)(Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112)