Colitis, Ulcerative
Conditions
Keywords
Ulcerative colitis, Ozanimod, colitis, Ulcerative
Brief summary
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.
Detailed description
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.
Interventions
DRUGOzanimod
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
OTHERPlacebo
The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria for Induction and Maintenance Periods 1. Subject is a Japanese male or female subjects aged 18 to 75 years at the time of signing the informed consent form (ICF) at Screening. 2. Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to first investigational product administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report. 3. Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy). 4. Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore of ≥ 2, a rectal bleeding score of ≥ 1, and a stool frequency score ≥ 1. Main Inclusion Criteria for Open-label Extension Period Subjects must satisfy the following criteria to be enrolled in the study: 1. Must have completed the Week 12 Visit and is non-responder at Week 12 2. Who completes the IP and enters the MP, completes participation through the last study treatment visit at Week 52 with maintaining clinical response, OR experiences disease relapse during the MP
Exclusion criteria
Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with clinical response | At Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with a clinical response | At Week 12 and Week 52 | 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 |
| Proportion of subjects with endoscopic improvement | At Week 12 and Week 52 | Defined as an endoscopy subscore of ≤ 1 point |
| Proportion of subjects with mucosal healing | At Week 12 and Week 52 | Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score \< 2.0 |
| Proportion of subjects with clinical remission | At Week 12 and Week 52 | 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 |
| Proportion of subject with clinical response | At week 52 | 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 |
| Proportion of subjects in remission while off corticosteroids for any length of time | Up to week 52 | Proportion of subjects in remission while off corticosteroids for any length of time |
| Adverse Event (AE) | From enrollment until at least 75 days after completion of study treatment | Number of participants with adverse event. |
| Change in the EuroQol-5 Dimension (EQ-5D) from baseline | At Week 12 | Is a quality of life questionnaires and will be collected from all subjects at visits |
Countries
Japan
Outcome results
None listed