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
- 84
- 试验地点
- 24
- 主要终点
- PART A: Geometric mean observed average concentration at steady state (Cavg.ss), maximum observed plasma concentration at steady state (Cmax), and trough observed plasma concentration (Ctrough) for deucravacitinib.
研究概览
简要总结
Part A: Pharmacokinetics: to evaluate the PK at steady-state of deucravacitinib in subjects in Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years) with moderate to severe plaque psoriasis Part B: Efficacy: to evaluate the efficacy of the standard dose of deucravacitinib vs placebo in subjects in Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years) with moderate to severe plaque psoriasis LTE Period: Safety: to characterize the safety/tolerability of deucravacitinib in pediatric subjects with moderate to severe plaque psoriasis
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 12 to < 18 years for Cohort 1 and aged 4 to < 12 years for Cohort
- •Diagnosed with stable (defined as no significant flares of disease activity or morphologic changes for 6 months) moderate to severe plaque psoriasis. Moderate to severe psoriasis defined by: (at screening visit and Day 1) Psoriasis Area and Severity Index (PASI) ≥ 12, // static Physician's Global Assessment (sPGA) ≥ 3, // Body Surface Area (BSA) ≥ 10% involvement.
- •Candidates for phototherapy or systemic therapy
- •LTE Period: For both Cohort 1 and Cohort 2, subjects must be willing to participate in the optional LTE period and must have the ability to sign the ICF or give assent as per local laws and regulations.
- •LTE Period: Written permission (informed consent) from parents (both, if required by local law), guardians, or legally acceptable representatives must be obtained and documented according to local laws and regulations
- •LTE Period: Subjects must have completed the Week 52 treatment period in Part A or B of the study.
排除标准
- •Subject has non-plaque forms of psoriasis (e.g. erythrodermic, guttate, inverse or pustular)
- •Subjects weighing < 30 Kg at screening
- •Subject has any of the following TB criteria: a) History of active TB prior to screening visit, regardless of completion of adequate treatment b) Signs or symptoms of active TB during screening as judged by the investigator c) A chest x-ray showing evidence of current active or old active pulmonary TB d) Latent TB infection (LTBI) defined as positive IGRA (QuantiFERON-TB Gold) at screening
- •Received live vaccine within 60 days or plan to receive a live vaccine during the study or plan to receive live vaccine within 60 days of last dose of study medication
- •Currently being treated with biologic agents
- •History of ongoing, chronic or recurrent infectious disease, and opportunistic infection regardless of successfully treatment
- •LTE Period: Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this treatment period, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason
- •LTE Period: Prior permanent discontinuation of study treatment in Part A or B of the study
- •LTE Period: Evidence of active TB
结局指标
主要结局
PART A: Geometric mean observed average concentration at steady state (Cavg.ss), maximum observed plasma concentration at steady state (Cmax), and trough observed plasma concentration (Ctrough) for deucravacitinib.
PART A: Geometric mean observed average concentration at steady state (Cavg.ss), maximum observed plasma concentration at steady state (Cmax), and trough observed plasma concentration (Ctrough) for deucravacitinib.
PART B: 1. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
PART B: 1. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
PART B: 2. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
PART B: 2. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
LTE Period: 1. AEs and SAEs
LTE Period: 1. AEs and SAEs
LTE Period: 2. Monitoring of growth including body weight and height and sexual maturation
LTE Period: 2. Monitoring of growth including body weight and height and sexual maturation
次要结局
未报告次要终点
研究者
GSM-CT Represntative
Scientific
Bristol-Myers Squibb Services Unlimited Company