A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Study Overview
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Brief Summary
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The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.

Official Title
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A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: OPC-6535
* Drug: OPC-6535


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary lesion in either small intestine or large intestine C-reactive protein (CRP) level above the upper limit of the normal range Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less Exclusion Criteria: Patients with an uncontrolled external fistula (including anal fistula) Patients with a history of total proctocolectomy or subtotal colectomy Patients with short bowel syndrome Patients with an artificial anus Patients with serious infectious disease (intra-abdominal abscess, etc) Patients with malignant tumor Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>oral administration of placebo once-daily for 8weeks | Drug: Placebo<br>* oral administration of placebo once-daily for 8 weeks<br>|
| Experimental: OPC-6535 25 mg<br>oral administration of OPC-6535 25 mg once-daily for 8 weeks | Drug: OPC-6535<br>* oral administration of OPC-6535 25 mg once-daily for 8 weeks<br>|
| Experimental: OPC-6535 50 mg<br>oral administration of OPC-6535 50mg once-daily for 8 weeks | Drug: OPC-6535<br>* oral administration of OPC-6535 50 mg once-daily for 8 weeks<br>|

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 × 100) After 8 Weeks of IMP Administration | Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: remission, CDAI > 450: severe disease) | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement Rate After 4 Weeks of IMP Administration | Definition of clinical improvement: CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: remission, CDAI > 450: severe disease) | Week 4 | 
| Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration | Definition of remission: Total CDAI score improved to below 150 | Weeks 4 and 8 | 
| Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration |  | Baseline, Weeks 4 and 8 |