中等度から重度のアトピー性皮膚炎の治療における単独または併用療法の有効性と安全性を評価する研究
基本情報
- NCT ID
- NCT06718101
- ステータス
- 募集中
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 80
- 治験依頼者名
- AbbVie
概要
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through multiple substudies. This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio. In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.
対象疾患
介入
依頼者(Sponsor)
実施施設 (4)
Kyoto University Hospital /ID# 275237
Kyoto, Kyoto, Japan(RECRUITING)
医療法人 北村皮膚科
Sapporo, Hokkaido, Japan(RECRUITING)
京都大学医学部附属病院
Kyoto, Kyoto, Japan(RECRUITING)
医療法人社団慈泰会 立川皮膚科クリニック
Tachikawa-shi, Tokyo, Japan(RECRUITING)