A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Study of AJM300 in Patients With Active Ulcerative Colitis

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: AJM300
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AJM300 960mg/dose<br>Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks. | Drug: AJM300<br>* AJM300 film-coated tablets.<br>* Other names: Carotegrast methyl;|
| Placebo Comparator: Placebo<br>Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks. | Drug: Placebo<br>* Placebo matched to AJM300 tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Week 8 | 
| Mucosal Healing Rate | Mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore <=1. | At Week 8 | 
| Complete Mucosal Healing Rate | Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 8 | 
| Change From Baseline in Fecal Calprotectin |  | Baseline, Week 8 | 
| Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts) |  | Baseline, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Inflammatory Bowel Disease, Ulcerative Colitis Type, Colitis, AJM300