日本人掌蹠膿疱症患者におけるアプレミラスト（CC-10004）の有効性および安全性を評価する研究
基本情報
- NCT ID
- NCT04057937
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 90
- 治験依頼者名
- Amgen
概要
This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations. The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.