Study Description

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.

• Condition or Disease:Colitis, Ulcerative
• Intervention/Treatment: Drug: Ozanimod
  Other: Placebo
• Phase: Phase 3

Detailed Description

Following the 4-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 52-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 Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Proportion of subjects with clinical response [ Time Frame: 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 Outcome Measures: 1. Proportion of subjects with clinical remission [ Time Frame: 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
• Secondary Outcome Measures: 2. Proportion of subjects in clinical remission measured at week 12- Rectal Bleeding [ Time Frame: Up to week 12 ]
  Defined as 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
• Secondary Outcome Measures: 3. Proportion of subjects with endoscopic improvement [ Time Frame: At Week 12 and Week 52 ]
  Defined as an endoscopy subscore of ≤ 1 point
• Secondary Outcome Measures: 4. Proportion of subjects with mucosal healing [ Time Frame: At Week 12 and Week 52 ]
  Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0
• Secondary Outcome Measures: 5. Proportion of subjects with a clinical response [ Time Frame: At Week 9 ]
  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
• Secondary Outcome Measures: 6. Change in the EuroQol-5 Dimension (EQ-5D) from baseline [ Time Frame: At Week 12 ]
  Is a quality of life questionnaires and will be collected from all subjects at visits
• Secondary Outcome Measures: 7. Proportion of subjects in clinical remission measured at week 52 - Mayo Score [ Time Frame: Up to week 52 ]
  Complete Mayo score of ≤ 2 points with no individual subscore of > 1 point
• Secondary Outcome Measures: 8. Proportion of subject with clinical response [ Time Frame: 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
• Secondary Outcome Measures: 9. Proportion of subjects in remission while off corticosteroids for any length of time [ Time Frame: Up to week 52 ]
  Proportion of subjects in remission while off corticosteroids for any length of time
• Secondary Outcome Measures: 10. Change in partial Mayo score from Baseline [ Time Frame: Up to week 64 ]
  Change in partial Mayo score from Baseline
• Secondary Outcome Measures: 11. Adverse Event (AE) [ Time Frame: From enrollment until at least 75 days after completion of study treatment ]
  Number of participants with adverse event.
• Secondary Outcome Measures: 12. Proportion of subjects in clinical remission measured at week 52- Rectal Bleeding [ Time Frame: Up to week 52 ]
  Defined as an endoscopy subscore of ≤ 1 point
• Secondary Outcome Measures: 13. Proportion of subject with clinical response at week 52 [ Time Frame: Up to 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
• Secondary Outcome Measures: 14. Proportion of subjects with endoscopic improvement [ Time Frame: Up to week 52 ]
  Defined as an endoscopy subscore of ≤ 1 point
• Secondary Outcome Measures: 15. Proportion of subjects with mucosal healing [ Time Frame: Up to week 52 ]
  Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0

Eligibility Criteria

Information from the National Library of Medicine

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• Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03915769 History of Changes
• Other Study ID Numbers: RPC01-3103, U1111-1230-3228
• First Posted: April 16, 2019 Key Record Dates
• Last Update Posted: February 8, 2022
• Last Verified: February 2022

• Individual Participant
  Data (IPD) Sharing
  Statement:

• Plan to Share IPD: Yes
• Plan Description: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
• Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
• Time Frame: See Plan Description
• Access Criteria: See Plan Description
• URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Celgene: Ulcerative colitis
  Ozanimod colitis
  Ulcerative
• Additional relevant MeSH terms: Colitis
  Colitis, Ulcerative
  Ulcer
  Gastroenteritis
  Gastrointestinal Diseases Digestive System Diseases
  Colonic Diseases
  Intestinal Diseases
  Pathologic Processes
  Inflammatory Bowel Diseases