NCT06979453招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 366
- 试验地点
- 232
- 主要终点
- Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
- •Participants must have moderate to severe psoriasis defined by:.
- •i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day
- •ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day
- •iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day
- •- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
- •i) Is not an individual of childbearing potential (IOCBP).
- •ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
排除标准
- •Participants must not weigh < 30.0 kg at Screening and Day
- •Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day
- •Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day
- •Participants must not have any untreated bacterial infection within 60 days prior to Day
- •Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).
- •Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.
- •Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention.
- •Participants must not have had any prior exposure to deucravacitinib.
- •Participants must not have received any medication that is specifically prohibited.
- •Participants must not have a laboratory finding that is exclusionary.
- •Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.
- •Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Administration of Deucravacitinib
Active Comparator
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
时间窗: At week 16
Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
时间窗: At week 16
次要结局
- Number of participants achieving at least 90% improvement in PASI (PASI 90)(At week 16)
- Change from baseline in PASI(At week 16)
- Change from baseline in body surface area (BSA) involvement(At week 16)
- Change from baseline in worst itch numeric rating scale (WI-NRS)(At week 16)
- Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)(At week 16)
- Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score(At week 16)
- Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2)(At week 16)
- Number of participants with treatment emergent adverse events(Up to 5 years)
- Number of participants with serious adverse events(Up to 5 years)
- Number of participants with clinically significant changes in laboratory parameters(Up to 5 years)
- Number of participants with clinically significant changes in physical examinations(Up to 5 years)
- Number of participants with protective titers of antibodies to tetanus(At week 16)
- Number of participants with protective titers of antibodies to pertussis(At week 16)
- Number of participants with clinically significant changes in vital signs(Up to 5 years)
- Number of participants with protective titers of antibodies to measles(At week 16)
- Body weight(Up to 5 years)
- Height(Up to 5 years)
- Sexual maturation(Up to 5 years)
研究者
研究点 (232)
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