Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.
Following the up to 5-week Screening Period, eligible subjects will be randomized to enter the 12 weeks placebo-controlled Induction Period (IP). Subjects who are responders at Week 12 will continue on their assigned treatment in the 40-week Maintenance Period (MP). Non responders at Week 12 have the option to enter the Open-label Extension (OLE). Subjects who complete the MP will be given the option to participate in the OLE. Subjects that enter the MP and experience disease relapse will also have the option to enter the OLE. The OLE will continue until marketing launch (about 4 years of ozanimod for Ulcerative colitis (UC), or until the Sponsor discontinues the development program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
Ozanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5
The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.
Proportion of subjects with clinical response
Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Time frame: At Week 12
Proportion of subjects with clinical remission
Defined as: Definition 1. Complete Mayo score of ≤ 2 points with no individual subscore of \> 1 point, Definition 2. Rectal bleeding subscore = 0 and stool frequency subscore ≤ 1 (and a decrease of ≥ 1 point from the Baseline stool frequency subscore) and endoscopy subscore ≤ 1
Time frame: At Week 12 and Week 52
Proportion of subjects with a clinical response
Defined as a reduction from Baseline in the 9-point Mayo score of ≥ 2 points and ≥ 35%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Time frame: At Week 12 and Week 52
Proportion of subjects with endoscopic improvement
Defined as an endoscopy subscore of ≤ 1 point
Time frame: At Week 12 and Week 52
Proportion of subjects with mucosal healing
Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score \< 2.0
Time frame: At Week 12 and Week 52
Proportion of subjects with a clinical response
Defined as a reduction from Baseline in the partial Mayo score of ≥ 2 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Time frame: At Week 9
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Local Institution - 104
Sapporo, Hokkaido, Japan
Local Institution - 105
Nishinomiya, Hyōgo, Japan
Local Institution - 156
Okayama, Okayama-ken, Japan
Local Institution - 153
Osaka, Osaka, Japan
Local Institution - 132
Osaka, Osaka-shi, Japan
Local Institution - 131
Iruma-gun, Saitama, Japan
Local Institution - 138
Bunkyo-ku, Tokyo, Japan
Local Institution - 139
Abiko, Japan
Local Institution - 152
Aki-gun, Japan
Local Institution - 122
Chikushino-shi, Japan
...and 57 more locations
Change in the EuroQol-5 Dimension (EQ-5D) from baseline
Is a quality of life questionnaires and will be collected from all subjects at visits
Time frame: At Week 12
Proportion of subject with clinical response
Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Time frame: At week 52
Proportion of subjects in remission while off corticosteroids for any length of time
Proportion of subjects in remission while off corticosteroids for any length of time
Time frame: Up to week 52
Adverse Event (AE)
Number of participants with adverse event.
Time frame: From enrollment until at least 75 days after completion of study treatment