JPRN-jRCT2031200152进行中（未招募）2 期
A Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients with NNS/CANDLE, SAVI, and AGS - I4V-JE-JAJE
Masaki Takeshi0 个研究点目标入组 5 人开始时间: 2020年10月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
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
- >= 6month old 至 ot applicable（—）
- 性别
- All
入选标准
- •Have systemic signs and symptoms of inflammation as manifested NNS/CANDLE, SAVI, AGS
- •- Have been diagnosed with genetic diagnosis
- •- Men must agree to use a reliable method of birth control during the study
- •- Women not of child-bearing potential or nonbreastfeeding
- •- Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- •- NNS/CANDLE and SAVI patients who are equal to or more than 17.5 months of age
- •- AGS patients who are equal to or more than 6 months of age
- •- Are equal to or more than 5kg in body weight
排除标准
- •- Have received immunosuppressive biologic agent/monoclonal antibody/oral JAK inhibitor/OAT3 inhibitor and cannot discontinue prior to investigational product initiation. Note: A washout period is required to each drug.
- •- Have diagnosis of current active tuberculosis (TB) or, latent TB who did not receive appropriate treatment.
- •- Have had a serious infection within 12 weeks prior to screening.
- •- Have a history of lymphoproliferative disease
- •- Have any history of venous thromboembolic event (VTE) (deep vein thrombosis [DVT]/pulmonary embolism [PE]) prior to screening.
- •- Have had any major surgery within 8 weeks prior to screening.
- •- Have previously been enrolled in any other study investigating baricitinib.
研究者
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