A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
研究概览
简要总结
This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.
详细描述
This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, 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 (PsA) for at least 6 months
- •Are candidates for phototherapy or systemic treatment of psoriasis
- •Have screening laboratory test results within the study parameters
排除标准
- •Currently have nonplaque forms of psoriasis
- •Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab
- •Received conventional systemic therapies or phototherapy within the last 4 weeks
- •Received biologic therapies within the last 3 months
研究组 & 干预措施
Ustekinumab Half-standard Dosage
Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
干预措施: Ustekinumab - Half-Standard Dosage (Drug)
Ustekinumab Half-standard Dosage
Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
干预措施: Placebo (Other)
Ustekinumab Standard Dosage
Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
干预措施: Ustekinumab - Standard Dosage (Drug)
Ustekinumab Standard Dosage
Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
干预措施: Placebo (Other)
Placebo
Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.
干预措施: Placebo (Other)
结局指标
主要结局
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
时间窗: Week 12
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
次要结局
- The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12(Week 12)
- The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups(Week 12)
- The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12(Week 12)
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups(Baseline; Week 12)
- The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12(Week 12)
- The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12(Week 12)
- The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1(Week 12)