To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

Study Overview
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Brief Summary
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To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.

Official Title
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A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: Budesonide (6 mg)
* Drug: Budesonide (9 mg)
* Drug: Mesalazine (3,600 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis. Diagnosis of ulcerative colitis in active phase of mild to moderate entity. Female patients must fulfill at least one of the following criteria: Post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period. Male patients must agree to use medically approved contraception throughout the trial period. Exclusion Criteria: Patients with limited distal proctitis. Patients with infectious colitis. Patients with history of colectomy. Patients with severe diseases in other organs and systems. Evidence or history of toxic megacolon. Women who wish to become pregnant during the trial period

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Budesonide (6 mg)<br> | Drug: Budesonide (6 mg)<br>* Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.<br>* Other names: FE 999315;|
| Experimental: Budesonide (9 mg)<br> | Drug: Budesonide (9 mg)<br>* Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.<br>* Other names: FE 999315;|
| Active Comparator: Mesalazine (3,600 mg)<br> | Drug: Mesalazine (3,600 mg)<br>* Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score | UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity. | After 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving clinical remission after 8 weeks of treatment |  | 8 weeks | 
| Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment |  | 8 weeks | 
| Percentage of subjects achieving clinical improvement after 8 weeks of treatment |  | 8 weeks | 
| Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1 |  | 8 weeks | 
| Percentage of subjects achieving symptom resolution after 2 weeks of treatment |  | 2 weeks | 
| Percentage of subjects achieving symptom resolution after 4 weeks of treatment |  | 4 weeks | 
| Percentage of subjects achieving symptom resolution after 8 weeks of treatment |  | 8 weeks | 
| Percentage of subjects with endoscopic healing after 8 weeks of treatment |  | 8 weeks | 
| Change from baseline in partial UCDAI score at 2 weeks |  | 2 weeks | 
| Change from baseline in partial UCDAI score at 4 weeks |  | 4 weeks | 
| Change from baseline in partial UCDAI score at 8 weeks |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, FE999315, Mesalazine, Colitis, Colitis, Ulcerative