A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Official Title
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A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: OPC-6535(Tetomilast)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with active ulcerative colitis Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose Either inpatient or outpatient Exclusion Criteria: Patients who have a history of intestinal resection (other than appendiceal resection) Patients who have a complication of malignant tumor Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OPC-6535(Tetomilast)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration | Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline | Weeks 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Definition of remission: DAI subscores for both rectal bleeding and mucosal appearance improved to 0 | Weeks 4 and 8 | 
| Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement. | Baseline, Weeks 4 and 8 | 
| Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change in mean score indicates improvement. | Baseline, Weeks 4 and 8 | 
| Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | CAI composed of 7 variables: number of stool weekly, blood in stools (weekly average), investigator's global assessment of symptomatic state, abdominal pain/cramps, temperature due to colitis, extraintestinal manifestations, and laboratory findings. The scores ranging from 0 to 29 points (higher scores meaning more severe disease). | Baseline, Weeks 2, 4 and 8 | 
| Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration | The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL. | Baseline and Week 8 | 
| Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ includes 32 items, which are divided into four subscales: bowel symptoms, systemic symptoms, emotional function and social function, and each item is scored on a 7-point scale, ranging from 1 (worst) to 7 (best). Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL. | Baseline and Week 8 | 
| Clinical Improvement Rate After 4 Weeks of Study Drug Administration | Definition of clinical improvement: DAI subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPC-6535, ulcerative colitis