中等度から重度の尋常性乾癬の小児患者におけるデュクラバシチニブの薬物濃度、有効性および安全性を評価する研究

基本情報

NCT ID

NCT04772079

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

153

治験依頼者名

Bristol-Myers Squibb

概要

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric 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 pediatric 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 pediatric participants with psoriasis who have completed Parts A or B of the study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)