JPRN-jRCT2080222367未知2 期
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of 3 dose of MEDI7183 Subcutaneously Administered in Japanese Subjects with Moderate to Severe Ulcerative Colitis
适应症
试验速览
- 阶段
- 2 期
- 发起方
- AstraZeneca
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
- >= 18age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •Provision of informed consent prior to any study specific procedures
- •- Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report
- •- Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy score 2 during screening period or more
- •- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-alpha agents.
排除标准
- •- Disease limited to the rectum
- •- Toxic megacolon
- •- Crohn's Disease
- •- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
- •- Planned bowel surgery within 12 weeks from Visit 2
- •- Stool positive for C. difficile toxin at screening
- •- Primary Sclerosing Cholangitis
- •- History of gastrointestinal surgery within 8 weeks of Visit 2
- •- Any uncontrolled or clinically significant systemic disease
- •- Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- •- Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc
研究者
相似试验
进行中（未招募）
不适用
Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid ArthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2011-006070-73-BGAstraZeneca AB130
已完成
2 期
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled,Parallel Group, Single-Season Study to Assess the Efficacy andSafety of HI-164OV Oral Vaccine in Moderate to Severe chronic obstructive pulmonary disease (COPD).Chronic Obstructive Pulmonary Disease (COPD)Respiratory - Chronic obstructive pulmonary diseaseACTRN12610000916044Hunter Immunology Limited340
进行中（未招募）
不适用
Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid ArthritisRheumatoid arthritisEUCTR2011-006070-73-CZAstraZeneca AB130
进行中（未招募）
不适用
Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid ArthritisMedDRA version: 15.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2011-006070-73-DEAstraZeneca AB130
进行中（未招募）
1 期
A multi-centre study comparing the effects of AZD2927 and placebo on the electrical activity in the heart in patients undergoing treatment for atrial flutterArrhythmiaMedDRA version: 14.0Level: PTClassification code 10003119Term: ArrhythmiaSystem Organ Class: 10007541 - Cardiac disordersEUCTR2011-001716-59-NOAstraZeneca AB60