Phase III study of AJM300 in patients with active ulcerative colitis (2)
Phase III study of AJM300 in patients with active ulcerative colitis (2)
EA Pharma Co., Ltd.
contact_ea@eapharma.co.jp
EA Pharma Co., Ltd.
contact_ea@eapharma.co.jp
completed
June. 06, 2018
198
Interventional
A randomized, double-blind, placebo-controlled, parallel-group, multi-center study
AJM300 960 mg group: 99 subjects
Placebo group: 99 subjects
treatment purpose
3
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
16age old over
74age old under
Both
Active Ulcerative Colitis
investigational material(s)
Generic name etc : AJM300
INN of investigational material : -
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investigational material : oral
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : oral
efficacy
-Clinical response rate as defined by the Mayo score
-The Mayo score
efficacy
Major secondary endpoins
-Clinical remission rate as defined by the Mayo score
-Mucosal healing rate
-Complete mucosal healing rate
-Percentage of rectal bleeding subscore of 0
-Time course of the fecal calprotectin
-The Mayo score
-The fecal calprotectin
EA Pharma Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
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Medical Corporation Shintokai Yokohama Minoru Clinic
