Phase-III Study of AJM300 in Patients with Active Ulcerative Colitis
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2080222810
- Lead Sponsor
- EA Pharma Co.,Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 165
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy by Mayo Score, Safety
- Secondary Outcome Measures
Name Time Method efficacy<br>Eficacy by Mayo score and clinical laboratory values.