Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese 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 determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.

Official Title
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A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: D9421-C, 9mg
* Drug: D9421-C, 15mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male aged ≥ 18 and ≤ 65 years Diagnosis of Crohn's Disease Exclusion Criteria: Having ileostomy or pouch and/or colostomy Having previous gastric surgery Having a known or suspected systemic infection

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>D9421-C 9 mg | Drug: D9421-C, 9mg<br>* D9421-C 9 mg was given once daily for 8 weeks.<br>|
| Active Comparator: 2<br>D9421-C 15 mg | Drug: D9421-C, 15mg<br>* D9421-C 15 mg was given once daily for 8 weeks.<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* D9421-C matching placebo was given once daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment | Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study. | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment | The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study. | Baseline to 2 weeks | 
| Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment | The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study. | Baseline to 4 weeks | 
| Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method | Time from randomisation to the remission of Crohn's disease defined as CDAI score  150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained. | At 8 weeks | 
| Change in CDAI Score From Baseline to 8 Weeks | CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured. | Baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal, GI, Crohn's disease, Japan, Japanese