A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate thePharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjectswith Moderate to Severe Plaque Psoriasis - IM011-126

Bristol Myers Squibb International Corporation0 个研究点目标入组 155 人开始时间: 2023年4月17日最近更新: 2024年7月22日

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•Males and females aged 12 to < 18 years for Cohort 1 and aged 4 to < 12 years for Cohort 2., 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.

•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

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