A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 132
- 主要终点
- Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
研究概览
简要总结
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to <18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 12 to <18 years for Cohort
- •Males and females aged 4 to <12 years for Cohort
- •Plaque psoriasis for at least 6 months.
- •Moderate to severe disease.
- •Candidate for phototherapy or systemic therapy.
- •Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.
排除标准
- •Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to < 18 years), Part A and Part B. Participants weighing < 18.0 kg at screening for Cohort 2 (age 4 to < 12 years), Part A and Part B.
- •Other forms of psoriasis.
- •History of recent infection.
- •Prior exposure to deucravacitinib (BMS-986165) or another active comparator.
- •Evidence of active TB for LTE period.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Placebo
干预措施: Placebo matching deucravacitinib (Other)
Active treatment deucravacitinib standard dose
干预措施: Deucravacitinib (Drug)
Active treatment deucravacitinib half-standard dose
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
时间窗: Week 16
Part B
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
时间窗: Week 2
Part A
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
时间窗: Week 2
Part A
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2
时间窗: Week 2
Part A
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16
时间窗: Week 16
Part B
Incidence of Adverse Events (AEs)
时间窗: Up to 316 weeks
Long-term extension (LTE) Period
Incidence of serious adverse events (SAEs)
时间窗: Up to 316 weeks
LTE Period
Monitoring of growth: Body weight
时间窗: Up to 316 weeks
LTE Period
Monitoring of growth: Height
时间窗: Up to 316 weeks
LTE Period
Monitoring of growth: Tanner staging (sexual maturation)
时间窗: Up to 316 weeks
LTE Period
次要结局
- Incidence of clinically significant changes in physical examination findings(Up to 466 days)
- Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests(Up to 368 days)
- Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests(Up to 368 days)
- Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only(Up to 466 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 466 days)
- Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure(Up to 466 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 466 days)
- Monitoring of growth: Body weight(Up to 466 days)
- Incidence of Adverse Events (AEs)(Up to 424 days)
- Incidence of serious adverse events (SAEs)(Up to 466 days)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 466 days)
- Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests(Up to 466 days)
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to 466 days)
- Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests(Up to 410 days)
- Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests(Up to 42 days)
- Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests(Up to 42 days)
- Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests(Up to 368 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 466 days)
- Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo(Week 16)
- Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo(Week 16)
- Incidence of clinically significant changes in lymphocyte subsets and function(Up to 466 days)
- Incidence of clinically significant changes in cytokine levels(Up to 466 days)
- Monitoring of growth: Tanner staging (sexual maturation)(Up to 466 days)
- Monitoring of growth: Height(Up to 466 days)
- Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo(Week 16)
- Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo(Week 16)
- Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo(Week 16)
- Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo(Week 16)
- Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo(Week 16)
- Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo(Week 16)
- Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline(Week 16)
- Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo(Week 16)
- Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16(Week 16)
- Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16(Week 16)
- Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time(Up to 316 weeks)
- Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16(Week 16)
- Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16(Week 16)
- Proportion of participants with 75% improvement in PASI (PASI 75) over time(Up to 316 weeks)