A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 191
- Primary Endpoint
- Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
oral administration of placebo once-daily for 8weeks
Intervention: Placebo (Drug)
OPC-6535 25 mg
oral administration of OPC-6535 25 mg once-daily for 8 weeks
Intervention: OPC-6535 (Drug)
OPC-6535 50 mg
oral administration of OPC-6535 50mg once-daily for 8 weeks
Intervention: OPC-6535 (Drug)
Outcomes
Primary Outcomes
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration
Time Frame: Week 8
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)
Secondary Outcomes
- Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration(Baseline, Weeks 4 and 8)
- Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration(Weeks 4 and 8)
- Clinical Improvement Rate After 4 Weeks of IMP Administration(Week 4)