Phase III study of AJM300 in patients with active ulcerative colitis (2)
- Conditions
- Active Ulcerative Colitis
- Registration Number
- JPRN-jRCT2080223867
- Lead Sponsor
- EA Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 198
Major Inclusion Criteria
1. Patients diagnosed with moderate ulcerative colitis
2. Patients with inadequate response or intolerant to oral 5-ASA
3. Patients who are capable of providing written informed consent
Major Exclution 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 efficacy<br>-Clinical response rate as defined by the Mayo score<br>-The Mayo score
- Secondary Outcome Measures
Name Time Method efficacy<br>Major secondary endpoins<br>-Clinical remission rate as defined by the Mayo score<br>-Mucosal healing rate <br>-Complete mucosal healing rate<br>-Percentage of rectal bleeding subscore of 0<br>-Time course of the fecal calprotectin<br><br>-The Mayo score<br>-The fecal calprotectin