JPRN-jRCT2080222810已完成3 期
Phase-III Study of AJM300 in Patients with Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
研究概览
简要总结
The primary endpoint, the clinical response rate by Mayo score in the AJM300 960 mg was not significantly higher than those in the placebo group, which did not verified the superiority of AJM300 to the placebo. On the other hand, the endoscopic improvement rate and the rectal bleeding disappearance rate in the secondary endpoints were statistically significant for AJM300 960 mg over placebo. The safety of AJM300 do not appear to raise any clinically significant concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •Patients with active-phase ulcerative colitis
- •-The Mayo score of 6 to 10
- •-Mucosal appearance subscore of 2 or more, and Rectal bleeding subscore of 1 or more
- •-Inadequate response or intolerance to oral 5-ASA or oral glucocorticoids
排除标准
- •Main exclusion criteria
- •1. Patients with extensive detachment of mucosa or deep ulcer
- •2.Patients with oral corticosteroid dependency
- •3.Patients with a complication of marked reduction of immune function
- •4.Patients who were clinically suspected to have a complication of infectious enteritis
- •5.Patients with a history or complication of serious infection within 1 year prior to the day of enrollment
- •6.Patients with CNS neurological symptoms
- •7.Patients with the following conditions:
- •-Serious heart disease
- •-Renal impairment
- •-Hepatic impairment
- •8.Patients with a history of serious drug induced allergy with unknown cause
- •9.Patients with malignant tumor or those whose treatments were completed in less than 5 years
- •10.Patients with apparent psychological signs
- •11.Pregnant women, nursing women, women with suspected pregnancy, women who wish to become pregnant during the period from informed consent through to the end of observation/examination at Week 8, and women who do not consent to the use of appropriate birth control methods.
- •12.Patients who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc
- •13.Patients of another clinical study including follow-up observation at the time of informed consent
- •14.Patients who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol
- •15.Patients who received investigational drugs in the study of AJM300
- •16.Patients determined to be ineligible for participation in this study by the investigator or sub-investigator
研究者
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