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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
Clinical Response Rate Based on Mayo Score
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.
Time frame: At Week 8
Clinical Remission Rate Based on Mayo Score
Clinical remission rate is defined by the percentage of participants with Mayo score \<=2 and no subscore greater than (\>) 1.
Time frame: At Week 8
Mucosal Healing Rate
Mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore \<=1.
Time frame: At Week 8
Complete Mucosal Healing Rate
Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0.
Time frame: At Week 8
Clinical Response Rate Based on Partial Mayo Score
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.
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AJM300/CT3 trial site 41
Nagoya, Aichi-ken, Japan
AJM300/CT3 trial site 57
Nagoya, Aichi-ken, Japan
AJM300/CT3 trial site 63
Nagoya, Aichi-ken, Japan
AJM300/CT3 trial site 9
Toyoake, Aichi-ken, Japan
AJM300/CT3 trial site 33
Toyohashi, Aichi-ken, Japan
AJM300/CT3 trial site 42
Toyota, Aichi-ken, 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
...and 72 more locations
Time frame: At Week 8
Clinical Remission Rate Based on Partial Mayo Score
Clinical remission rate is defined by the percentage of participants with partial Mayo score \<=2 and no subscore \>1.
Time frame: At Week 8
Modified Clinical Remission Rate 1
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.
Time frame: At Week 8
Modified Clinical Remission Rate 2
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.
Time frame: At Week 8
Percentage of Rectal Bleeding Subscore of 0
Percentage of rectal bleeding subscore of 0 means the percentage of participants with rectal bleeding score =0.
Time frame: At Week 8
Change From Baseline in Mayo score
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.
Time frame: Baseline, Week 8
Change From Baseline in Partial Mayo Score
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.
Time frame: Baseline, Week 8
Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Week 8
Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts)
Time frame: Baseline, Week 8