To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 15 January 2024
• Main ID: NCT03915769
• Date of registration: 12/04/2019
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
• Scientific title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: June 3, 2019
• Target sample size: 195
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03915769
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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 Exclusion Criteria

1. Subject has severe extensive colitis

2. Subject has diagnosis of Crohn's disease or indeterminate colitis or the presence or
history of a fistula consistent with Crohn's disease or microscopic colitis or
radiation colitis or ischemic colitis.

3. Subject has positive stool examination for pathogens (ova and parasites, bacteria) or
positive test for toxin producing Clostridium difficile (C. difficile) at Screening.4.
Subject is pregnant or breastfeeding

5. Subject has clinically relevant cardiovascular conditions



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Ozanimod

Other: Placebo

Primary Outcome(s)

Proportion of subjects with clinical response [Time Frame: At Week 12]

Secondary Outcome(s)

Change in the EuroQol-5 Dimension (EQ-5D) from baseline [Time Frame: At Week 12]

Proportion of subjects in remission while off corticosteroids for any length of time [Time Frame: Up to week 52]

Proportion of subjects with clinical remission [Time Frame: At Week 12 and Week 52]

Proportion of subjects with endoscopic improvement [Time Frame: At Week 12 and Week 52]

Proportion of subjects with mucosal healing [Time Frame: At Week 12 and Week 52]

Adverse Event (AE) [Time Frame: From enrollment until at least 75 days after completion of study treatment]

Proportion of subject with clinical response [Time Frame: At week 52]

Proportion of subjects with a clinical response [Time Frame: At Week 12 and Week 52]

Proportion of subjects with a clinical response [Time Frame: At Week 9]

Secondary ID(s)

RPC01-3103

U1111-1230-3228

Source(s) of Monetary Support

Please refer to primary and secondary sponsors