A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease

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

Official Title
-----------------
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease

Conditions
-----------------
Crohn Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with active Crohn's disease Patients who have a primary lesion in either the small intestine or the large intestine Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less Either inpatient or outpatient Exclusion Criteria: Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents) Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake) Patients with an artificial anus Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.) 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
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
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: 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 2 and 4 Weeks of Study Drug Administration | Definition of clinical improvement: Total CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Week 2, Week 4 | 
| Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration | Definition of remission: Total CDAI score improved to below 150 | Week 2, Week 4，Week 8 | 
| Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration | Definition of clinical improvement (50) : Total CDAI score improved by at least 50 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Baseline, Weeks 2, 4, and 8 | 
| Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration | CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity (CDAI < 150: Remission, CDAI > 450: Very severe). A negative change in mean score indicates improvement. | 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 patients 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, Week 8 | 
| Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration | Large bowel endoscopic findings were assessed based on the CDEIS. The CDEIS considers deep ulcer, superficial ulcer, lesion ratio of , and ulcer ratio of the 5 pre-defined segments of the colon (small intestine, right colon, transverse colon, left colon, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe disease. | Baseline, Week 8 | 
| Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration |  | Baseline, Weeks 4 and 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OPC-6535, Crohn's disease