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

NCT03915769 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: RPC01-3103U1111-1230-3228
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 67

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.

Conditions

Colitis, Ulcerative

Keywords

Ulcerative colitis; Ozanimod; colitis; Ulcerative

Outcome Measures

Primary Outcomes (1)

• 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

  At Week 12

Secondary Outcomes (9)

• Proportion of subjects with clinical remission

  At Week 12 and Week 52

• Proportion of subjects with a clinical response

  At Week 12 and Week 52

• Proportion of subjects with endoscopic improvement

  At Week 12 and Week 52

• Proportion of subjects with mucosal healing

  At Week 12 and Week 52

• Proportion of subjects with a clinical response

  At Week 9

Study Arms (3)

0.46 mg ozanimod oral capsule once daily (QD)

EXPERIMENTAL

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.

Drug: Ozanimod

0.92 mg ozanimod oral capsule QD

EXPERIMENTAL

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.

Drug: Ozanimod

Placebo oral capsule QD

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Ozanimod 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

0.46 mg ozanimod oral capsule once daily (QD); 0.92 mg ozanimod oral capsule QD

Placebo OTHER

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

Placebo oral capsule QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy).
• 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:
• Must have completed the Week 12 Visit and is non-responder at Week 12
• 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

You may not qualify if:

• Subject has severe extensive colitis
• 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.
• 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
• \. Subject has clinically relevant cardiovascular conditions

Sponsors & Collaborators

• Celgene: lead

Study Sites (67)

Local Institution - 104

Sapporo, Hokkaido, 060-8543, Japan

Location

Local Institution - 105

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Local Institution - 156

Okayama, Okayama-ken, 700-8558, Japan

Location

Local Institution - 153

Osaka, Osaka, 530-0052, Japan

Location

Local Institution - 132

Osaka, Osaka-shi, 545-8586, Japan

Location

Local Institution - 131

Iruma-gun, Saitama, 3500495, Japan

Location

Local Institution - 138

Bunkyo-ku, Tokyo, 1138519, Japan

Location

Local Institution - 139

Abiko, 270-1168, Japan

Location

Local Institution - 152

Aki-gun, 735-8585, Japan

Location

Local Institution - 122

Chikushino-shi, 818-8502, Japan

Location

Local Institution - 150

Fujiidera, 538-0027, Japan

Location

Local Institution - 114

Fukui, 910-8526, Japan

Location

Local Institution - 124

Fukui, 918-8503, Japan

Location

Local Institution - 161

Fukuoka, 810-0001, Japan

Location

Local Institution - 164

Fukuoka, 812-0033, Japan

Location

Local Institution - 155

Fukuoka, 815-8555, Japan

Location

Local Institution - 140

Gifu, 500-8717, Japan

Location

Local Institution - 151

Hakodate, 040-8611, Japan

Location

Local Institution - 133

Hirosaki, 036-8203, Japan

Location

Local Institution - 160

Hiroshima, 734-8530, Japan

Location

Local Institution - 106

Hiroshima, 734-8551, Japan

Location

Local Institution - 126

Hitachi, Ibaraki, 317-0077, Japan

Location

Local Institution - 162

Iizuka, 820-8505, Japan

Location

Local Institution - 134

Isehara City, Kanagawa, 259-1193, Japan

Location

Local Institution - 120

Kahoku-gun, 920-0293, Japan

Location

Local Institution - 135

Kannonji, 769-1695, Japan

Location

Local Institution - 101

Kashihara, 634-8522, Japan

Location

Local Institution - 158

Kashiwa, 277-0871, Japan

Location

Local Institution - 157

Kawagoe, 350-8550, Japan

Location

Local Institution - 163

Kobe, 650-0015, Japan

Location

Local Institution - 130

Kobe, 650-0017, Japan

Location

Local Institution - 121

Komatsu, 923-8560, Japan

Location

Local Institution - 144

Kōriyama, 963-8501, Japan

Location

Local Institution - 142

Kurume, 830-8543, Japan

Location

Local Institution - 165

Kurume, 839-0809, Japan

Location

Local Institution - 111

Kurume, Fukuoka, 830-0011, Japan

Location

Local Institution - 141

Kyoto, 602-8566, Japan

Location

Local Institution - 118

Matsuyama, 790-0024, Japan

Location

Local Institution - 108

Minatoku, 105-8471, Japan

Location

Local Institution - 107

Minatoku, 108-8642, Japan

Location

Local Institution - 109

Mitaka, 181-8611, Japan

Location

Local Institution - 110

Morioka, 020-8505, Japan

Location

Local Institution - 125

Nagaoka, 940-8653, Japan

Location

Local Institution - 167

Nagoya, 466-8560, Japan

Location

Local Institution - 136

Okayama, 700-0013, Japan

Location

Local Institution - 127

Osaki-shi, 989-6183, Japan

Location

Local Institution - 119

Ōgaki, 503-8502, Japan

Location

Local Institution - 159

Ōita, 870-0823, Japan

Location

Local Institution - 113

Ōtsu, 520-2192, Japan

Location

Local Institution - 154

Saga, 849-8501, Japan

Location

Local Institution - 116

Saitama, 336-0963, Japan

Location

Local Institution - 145

Sakai, 591-8025, Japan

Location

Local Institution - 102

Sakura, 285-8741, Japan

Location

Local Institution - 103

Sapporo, 060-0033, Japan

Location

Local Institution - 147

Sapporo, 062-8618, Japan

Location

Local Institution - 146

Sendai, 980-0021, Japan

Location

Local Institution - 128

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Local Institution - 117

Shinjuku, 169-0073, Japan

Location

Local Institution - 137

Shizuoka, 420-8630, Japan

Location

Local Institution - 149

Sunto-gun, 411-8611, Japan

Location

Local Institution - 112

Takamatsu, 760-8557, Japan

Location

Local Institution - 115

Takatsuki, 569-0086, Japan

Location

Local Institution - 143

Takatsuki, 569-1096, Japan

Location

Local Institution - 166

Toshima-ku, 171-0021, Japan

Location

Local Institution - 129

Toyama, 939-8511, Japan

Location

Local Institution - 123

Tsu, 514-8507, Japan

Location

Local Institution - 148

Utsunomiya, 320-0003, Japan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis; Ulcer

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: June 3, 2019
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (67)