A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
- Registration Number
- NCT03531892
- Lead Sponsor
- EA Pharma Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
-
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 (>=) 2.
- Rectal bleeding subscore >=1.
-
Participants with inadequate response or intolerant to oral 5-ASA
-
Participants who are capable of providing written informed consent
Major
-
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 AJM300.
-
Participants determined to be ineligible for participation in this study by the investigator or sub-investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks. AJM300 960mg/dose AJM300 Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks.
- Primary Outcome Measures
Name Time Method Clinical Response Rate Based on Mayo Score 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.
- Secondary Outcome Measures
Name Time Method Clinical Response Rate Based on Partial Mayo Score 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 partial Mayo score and the change or the actual value of individual subscales. Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding 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 partial Mayo score ranges from 0 to 9, with higher scores indicating more severe disease.
Modified Clinical Remission Rate 1 At Week 8 Modified Clinical remission rate 1 is defined by percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, Stool frequency subscore =0 and Endoscopic subscore \<=1.
Mucosal Healing Rate At Week 8 Mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore \<=1.
Change From Baseline in Fecal Calprotectin Baseline, Week 8 Complete Mucosal Healing Rate At Week 8 Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0.
Change From Baseline in Mayo score Baseline, Week 8 Mayo score is used in clinical trials to assess 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.
Clinical Remission Rate Based on Partial Mayo Score At Week 8 Clinical remission rate is defined by the percentage of participants with partial Mayo score \<=2 and no subscore \>1.
Modified Clinical Remission Rate 2 At Week 8 Modified Clinical remission rate 2 is defined by the percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, a decrease in the stool frequency subscore of at least 1 point or an absolute stool frequency subscore of 0 or 1 and Endoscopic subscore \<=1.
Percentage of Rectal Bleeding Subscore of 0 At Week 8 Percentage of rectal bleeding subscore of 0 means the percentage of participants with rectal bleeding score =0.
Clinical Remission Rate Based on Mayo Score At Week 8 Clinical remission rate is defined by the percentage of participants with Mayo score \<=2 and no subscore greater than (\>) 1.
Change From Baseline in Partial Mayo Score Baseline, Week 8 Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding 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 9, with higher scores indicating more severe disease.
Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts) Baseline, Week 8
Trial Locations
- Locations (82)
AJM300/CT3 trial site 41
🇯🇵Nagoya, Aichi, Japan
AJM300/CT3 trial site 57
🇯🇵Nagoya, Aichi, Japan
AJM300/CT3 trial site 63
🇯🇵Nagoya, Aichi, Japan
AJM300/CT3 trial site 9
🇯🇵Toyoake, Aichi, Japan
AJM300/CT3 trial site 33
🇯🇵Toyohashi, Aichi, Japan
AJM300/CT3 trial site 42
🇯🇵Toyota, Aichi, Japan
AJM300/CT3 trial site 39
🇯🇵Hirosaki, Aomori, Japan
AJM300/CT3 trial site 49
🇯🇵Hirosaki, Aomori, Japan
AJM300/CT3 trial site 11
🇯🇵Kashiwa, Chiba, Japan
AJM300/CT3 trial site 51
🇯🇵Kashiwa, Chiba, Japan
Scroll for more (72 remaining)AJM300/CT3 trial site 41🇯🇵Nagoya, Aichi, Japan