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

NCT ID: NCT03915769

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2025-09-30

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.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.46 mg ozanimod oral capsule once daily (QD)

It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.46 mg ozanimod.

Group Type: EXPERIMENTAL

Ozanimod

Intervention Type: DRUG

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

0.92 mg ozanimod oral capsule QD

It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.92 mg ozanimod.

Group Type: EXPERIMENTAL

Ozanimod

Intervention Type: DRUG

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

Placebo oral capsule QD

It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with a placebo capsule, followed by 3 days of treatment with two placebo capsules, followed by two placebo capsules.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.

Interventions

Ozanimod

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

Intervention Type: DRUG

Placebo

The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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

Local Institution - 150

Fujiidera, , Japan

Local Institution - 114

Fukui, , Japan

Local Institution - 124

Fukui, , Japan

Local Institution - 161

Fukuoka, , Japan

Local Institution - 164

Fukuoka, , Japan

Local Institution - 155

Fukuoka, , Japan

Local Institution - 140

Gifu, , Japan

Local Institution - 151

Hakodate, , Japan

Local Institution - 133

Hirosaki, , Japan

Local Institution - 160

Hiroshima, , Japan

Local Institution - 106

Hiroshima, , Japan

Local Institution - 126

Hitachi, Ibaraki, , Japan

Local Institution - 162

Iizuka, , Japan

Local Institution - 134

Isehara City, Kanagawa, , Japan

Local Institution - 120

Kahoku-gun, , Japan

Local Institution - 135

Kannonji, , Japan

Local Institution - 101

Kashihara, , Japan

Local Institution - 158

Kashiwa, , Japan

Local Institution - 157

Kawagoe, , Japan

Local Institution - 163

Kobe, , Japan

Local Institution - 130

Kobe, , Japan

Local Institution - 121

Komatsu, , Japan

Local Institution - 144

Kōriyama, , Japan

Local Institution - 142

Kurume, , Japan

Local Institution - 165

Kurume, , Japan

Local Institution - 111

Kurume, Fukuoka, , Japan

Local Institution - 141

Kyoto, , Japan

Local Institution - 118

Matsuyama, , Japan

Local Institution - 108

Minatoku, , Japan

Local Institution - 107

Minatoku, , Japan

Local Institution - 109

Mitaka, , Japan

Local Institution - 110

Morioka, , Japan

Local Institution - 125

Nagaoka, , Japan

Local Institution - 167

Nagoya, , Japan

Local Institution - 136

Okayama, , Japan

Local Institution - 127

Osaki-shi, , Japan

Local Institution - 119

Ōgaki, , Japan

Local Institution - 159

Ōita, , Japan

Local Institution - 113

Ōtsu, , Japan

Local Institution - 154

Saga, , Japan

Local Institution - 116

Saitama, , Japan

Local Institution - 145

Sakai, , Japan

Local Institution - 102

Sakura, , Japan

Local Institution - 103

Sapporo, , Japan

Local Institution - 147

Sapporo, , Japan

Local Institution - 146

Sendai, , Japan

Local Institution - 128

Shinagawa-ku, Tokyo, , Japan

Local Institution - 117

Shinjuku, , Japan

Local Institution - 137

Shizuoka, , Japan

Local Institution - 149

Sunto-gun, , Japan

Local Institution - 112

Takamatsu, , Japan

Local Institution - 115

Takatsuki, , Japan

Local Institution - 143

Takatsuki, , Japan

Local Institution - 166

Toshima-ku, , Japan

Local Institution - 129

Toyama, , Japan

Local Institution - 123

Tsu, , Japan

Local Institution - 148

Utsunomiya, , Japan

Countries

Japan

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

U1111-1230-3228

Identifier Type: REGISTRY

Identifier Source: secondary_id

RPC01-3103

Identifier Type: -

Identifier Source: org_study_id