A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- Percentage of Participants With 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 demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).
详细描述
A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.
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
- 20 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-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening
- •Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline
- •Have an IGA >= 3 at Screening and at Baseline
- •Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
- •Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
排除标准
- •Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances
- •Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening
- •Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening
- •Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
- •Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
研究组 & 干预措施
Group 1
Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter.
干预措施: CNTO 1959 50 mg (Drug)
Group 1
Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter.
干预措施: Placebo 100 mg (Drug)
Group 2
Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter.
干预措施: CTNO 1959 100 mg (Drug)
Group 2
Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter.
干预措施: Placebo 50 mg (Drug)
Group 3
Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
干预措施: CNTO 1959 50 mg (Drug)
Group 3
Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
干预措施: CTNO 1959 100 mg (Drug)
Group 3
Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
干预措施: Placebo 50 mg (Drug)
Group 3
Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
干预措施: Placebo 100 mg (Drug)
结局指标
主要结局
Percentage of Participants With 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 participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Percentage of Participants Who Achieved 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 the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-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. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
次要结局
- Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48(Baseline and Week 48)
- Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52(Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
- Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16(Baseline and Weeks 2, 4, 8, 12, 16)
- Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52(Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Percentage of Participants Who Achieved PASI 75 Response at Week 16(Week 16)
- Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16(Baseline and Week 16)
- Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
- Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52(Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16(Baseline and Weeks 2, 4, 8, 12, 16)
- Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52(Baseline and Weeks 28, 36, 48, 52)
- Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16(Weeks 8 and 16)
- Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52(Weeks 28, 36, 48, and 52)
- Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52(Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52)
- Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16(Baseline and Week 16)
- Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52(Baseline and Weeks 28, 36, 48, 52)
- Percent Change From Baseline in NAPSI Score at Week 16(Baseline and Week 16)
- Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52(Baseline and Weeks 28, 36, 48, 52)
- Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16(Week 16)
- Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52(Week 28, 48 and 52)
- Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16(Week 16)
- Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52(Week 28, 48 and 52)
- Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16(Weeks 8 and 16)
- Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52(Weeks 28, 36, 48, and 52)
- Change From Baseline in the DLQI Total Score at Week 8(Baseline and Weeks 8)
- Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16(Baseline and Week 16)
- Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48(Baseline and Weeks 28, 48)
- Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16(Baseline and Week 16)
- Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48(Baseline and Weeks 28, 48)
- Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16(Baseline and Week 16)
- Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48(Baseline and Weeks 28, 48)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16(Baseline and Week 16)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48(Baseline and Weeks 28, 48)
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16(Weeks 4, 8, and 16)
- Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52(Weeks 28, 36, 48, and 52)
- Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16(Weeks 4, 8, and 16)
- Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52(Weeks 28, 36, 48, and 52)
- Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16(Baseline and Weeks 4, 8, 16)
- Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52(Baseline and Weeks 28, 36, 48, 52)
- Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16(Baseline and Weeks 4, 8, 16)
- Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52(Baseline and Weeks 28, 36, 48, 52)
- Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16(Baseline and Weeks 4, 8, 16)
- Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52(Baseline and Weeks 28, 36, 48, 52)
- Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16(Weeks 4, 8, and 16)
- Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52(Weeks 28, 36, 48, 52)