跳至主要内容
临床试验/JPRN-jRCT2031230139
JPRN-jRCT2031230139招募中3 期

Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric Patients with Atopic Dermatitis

Yamane Satoshi0 个研究点目标入组 150 人开始时间: 2023年6月16日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 2age old 至 <= 11age old(—)
性别
All

入选标准

  • 1. Japanese patients aged between 2 and 11 years at informed consent who can visit the study site as an outpatient
  • 2. Patients with clinical diagnosis of AD according to the criteria of the Japanese Dermatological Association prior to or at informed consent
  • 3. Patients whose IGA score, EASI score, and %BSA affected meet the criteria specified in the study protocol

排除标准

  • 1. Patients with a history of or current significant dermatologic or inflammatory condition that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study
  • 2. Patients with a history of or current acute active bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, and varicella) skin infection within 1 week prior to Week 0
  • 3. Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0
  • 4. Patients with serious concomitant disease(s)
  • 5. Patients with a history of or current cancer within 5 years prior to screening visit

研究者

发起方
Yamane Satoshi

相似试验