A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO 1959 for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis (X-PLORE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Janssen Inc.
- 入组人数
- 293
- 主要终点
- Percentage of Participants With Physician Global Assessment (PGA) 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 and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.
详细描述
This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
- •Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
- •Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
- •If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
- •If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.
排除标准
- •History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- •Has a contra-indication to anti-TNF therapy
- •Has a history of chronic or recurrent infectious disease
- •Has a nonplaque form of psoriasis or has drug-induced psoriasis
- •Has been previously treated with adalimumab
- •Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and SCH900222) within 6 months of the first administration of study agent.
研究组 & 干预措施
CNTO 1959 (5 mg)
CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
干预措施: CNTO 1959 (5 mg) (Drug)
CNTO 1959 (15 mg)
CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
干预措施: CNTO 1959 (15 mg) (Drug)
CNTO 1959 (50 mg)
CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
干预措施: CNTO 1959 (50 mg) (Drug)
CNTO 1959 (100 mg)
CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
干预措施: CNTO 1959 (100 mg) (Drug)
CNTO 1959 (200 mg)
CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
干预措施: CNTO 1959 (200 mg) (Drug)
Adalimumab (approved psoriasis dosing)
Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.)
干预措施: Adalimumab (Drug)
Placebo to CNTO 1959 (100 mg)
Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
干预措施: CNTO 1959 (100 mg) (Drug)
Placebo to CNTO 1959 (100 mg)
Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16
时间窗: Week 16
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
次要结局
- Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40(Week 40)
- Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16(Week 16)
- Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16(Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16(Baseline and Week 16)