A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatrict Subjects with Moderate to Severe Plaque Psoriasis

Bristol-Myers Squibb International Corporation0 个研究点目标入组 153 人开始时间: 2021年2月15日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•- Male 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:
•- Subjects must be willing to participate in the optional LTE period and must have the ability to sign the ICF.
•- Subjects must have completed the Week 52 treatment period in Part A or B of the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 153
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Subject has non-plaque forms of psoriasis (e.g. erythrodermic, guttate, inverse or pustular)
•2. Subjects weighing < 30 Kg at screening
•3. 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
•4. 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
•5. Currently being treated with biologic agents
•6. History of ongoing, chronic or recurrent infectious disease, and opportunistic infection regardless of successfully treatment
•LTE Period:
•a) 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
•b) Prior permanent discontinuation of study treatment in Part A or B of the study c) Evidence of active TB (see Section 9.4.4)

发起方