AJM300
DrugAJM300 film-coated tablets.
Other names: Carotegrast methyl
NCT Number: NCT03531892
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.
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Notify Me16 year–74 year
All sexes
Interventional
Phase 3
AJM300/CT3 trial site 41, Nagoya, Aichi-ken, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Major Inclusion Criteria:
Major Exclusion Criteria:
AJM300 film-coated tablets.
Other names: Carotegrast methyl
Placebo matched to AJM300 tablets.
Time frame: 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.
Time frame: At Week 8
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 is defined by the percentage of participants with Mayo endoscopic subscore <=1.
Time frame: At Week 8
Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0.
Time frame: 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.
Time frame: At Week 8
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 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 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 means the percentage of participants with rectal bleeding score =0.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 8
Time frame: Baseline, Week 8
EA Pharma Co., Ltd.
Industry
Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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