Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 82
- 主要终点
- Clinical Response Rate Based on Mayo Score
研究概览
简要总结
The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with ulcerative colitis.
- •Participants with moderate ulcerative colitis who satisfy all of the following criteria at Day of enrollment.
- •Mayo Clinic scores of 6-10 .
- •Endoscopic subscore greater than or equal to (>=)
- •Rectal bleeding subscore >=
- •Participants with inadequate response or intolerant to oral 5-ASA
- •Participants who are capable of providing written informed consent
排除标准
- •Participants with extensive detachment of mucosa or deep ulcer.
- •Participants with oral corticosteroid dependency.
- •Participants with a complication of marked reduction of immune function.
- •Participants who were clinically suspected to have a complication of infectious enteritis.
- •Participants with a history or complication of serious infection within 1 year prior to the day of enrollment.
- •Participants with central nervous system (CNS) neurological symptoms.
- •Participants with the following criteria:
- •Serious heart disease
- •Renal impairment
- •Hepatic impairment
- •Participants with a history of serious drug induced allergy with unknown cause.
- •Participants with malignant tumor or those whose treatments were completed in less than 5 years.
- •Participants with apparent psychological signs.
- •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.
- •Participants who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc.
- •Participants who are participants of another clinical study including follow-up observation at the time of informed consent.
- •Participants who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol.
- •Participants who received investigational drugs in the study of AJM
- •Participants determined to be ineligible for participation in this study by the investigator or sub-investigator.
研究组 & 干预措施
AJM300 960mg/dose
Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks.
干预措施: AJM300 (Drug)
Placebo
Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Response Rate Based on Mayo Score
时间窗: At Week 8
Clinical response rate is defined by the percentage of participants who satisfy the combined definition of the change of the total value of Mayo score and the change or the actual value of individual subscales. Mayo score is used in clinical trials to assess ulcerative colitis (UC) disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
次要结局
- Clinical Response Rate Based on Partial Mayo Score(At Week 8)
- Modified Clinical Remission Rate 1(At Week 8)
- Clinical Remission Rate Based on Mayo Score(At Week 8)
- Mucosal Healing Rate(At Week 8)
- Change From Baseline in Fecal Calprotectin(Baseline, Week 8)
- Complete Mucosal Healing Rate(At Week 8)
- Change From Baseline in Mayo score(Baseline, Week 8)
- Clinical Remission Rate Based on Partial Mayo Score(At Week 8)
- Modified Clinical Remission Rate 2(At Week 8)
- Percentage of Rectal Bleeding Subscore of 0(At Week 8)
- Change From Baseline in Partial Mayo Score(Baseline, Week 8)
- Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts)(Baseline, Week 8)