中等度から重度のアトピー性皮膚炎の青年に対するトラロキヌマブ単独療法 - ECZTRA 6 (ECZema TRAlokinumab 試験番号 6)。

基本情報

NCT ID: NCT03526861
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 301
治験依頼者名: LEO Pharma

概要

Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.

対象疾患

Atopic Dermatitis

介入

Tralokinumab(DRUG)

Placebos(DRUG)