JPRN-jRCT2031210521招募中3 期
Phase 3 Study of MT-0551 in Patients with Systemic Sclerosis (Placebo-Controlled Double-Blind Study)
Kondou Kazuoki0 个研究点目标入组 80 人开始时间: 2021年12月26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
- 80
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
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •(1)ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.
- •(2)Skin thickening score based on the mRTSS between 10 and 22 inclusive.
排除标准
- •(1)Pulmonary hypertension associated with SSc.
- •(2)Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
- •(3)Finding of inadequate respiratory reserve capacity.
- •(4)Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.
- •(5)Presence of a clinically significant active infection requiring antimicrobial therapy.
- •(6)A past history of cancer.
- •(7)Past history of a recurrent, clinically significant infection.
- •(8)Past history of severe allergy or anaphylactic reaction to a biologic drug product.
- •(9)Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).
研究者
相似试验
未知
1 期
Phase 1/2 study of NS-065/NCNP-01 in patients with Duchenne muscular dystrophyDuchenne muscular dystrophyJPRN-jRCT2080223236IPPON SHINYAKU CO., LTD.16
未知
2 期
Phase II clinical study of TY-51924 in patients with acute myocardial infarction - Pilot studyAcute myocardial infarctionJPRN-jRCT2080221349TOA EIYO LTD.
未知
2 期
Proof of concept study of TY-51924 in patients with acute myocardial infarctioAcute myocardial infarctionJPRN-jRCT2080221705TOA EIYO LTD.100
已完成
2 期
REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer2023-506248-18-00Regeneron Pharmaceuticals Inc.35
招募中
1 期
REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung CancerMET-altered non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2023-506248-18-00Regeneron Pharmaceuticals Inc.101