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New daily pill could tame ulcerative colitis in japanese patients

NCT ID NCT03915769

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two doses of a daily pill called ozanimod in 198 Japanese adults with moderate to severe ulcerative colitis. The goal was to see if it could reduce symptoms and inflammation better than a placebo. The trial also checked long-term safety. Ozanimod works by calming the immune system to help control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ozanimod (a daily pill that helps calm the immune system)
What this could lead to
If successful, ozanimod could offer a new daily pill option for Japanese patients with moderate to severe ulcerative colitis to control their disease and reduce symptoms.
What could go wrong
This is a completed trial, but results are not yet widely available. Ozanimod may not work for everyone and can have side effects like slow heart rate or infections. Long-term safety is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

198 people

The number who actually took part.

Started

Jun 2019

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colitis ulcer disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative

Contacts and locations

Locations

  • Local Institution - 101

    Kashihara, 634-8522, Japan

  • Local Institution - 102

    Sakura, 285-8741, Japan

  • Local Institution - 103

    Sapporo, 060-0033, Japan

  • Local Institution - 104

    Sapporo, Hokkaido, 060-8543, Japan

  • Local Institution - 105

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Local Institution - 106

    Hiroshima, 734-8551, Japan

  • Local Institution - 107

    Minatoku, 108-8642, Japan

  • Local Institution - 108

    Minatoku, 105-8471, Japan

  • Local Institution - 109

    Mitaka, 181-8611, Japan

  • Local Institution - 110

    Morioka, 020-8505, Japan

  • Local Institution - 111

    Kurume, Fukuoka, 830-0011, Japan

  • Local Institution - 112

    Takamatsu, 760-8557, Japan

  • Local Institution - 113

    Ōtsu, 520-2192, Japan

  • Local Institution - 114

    Fukui, 910-8526, Japan

  • Local Institution - 115

    Takatsuki, 569-0086, Japan

  • Local Institution - 116

    Saitama, 336-0963, Japan

  • Local Institution - 117

    Shinjuku, 169-0073, Japan

  • Local Institution - 118

    Matsuyama, 790-0024, Japan

  • Local Institution - 119

    Ōgaki, 503-8502, Japan

  • Local Institution - 120

    Kahoku-gun, 920-0293, Japan

  • Local Institution - 121

    Komatsu, 923-8560, Japan

  • Local Institution - 122

    Chikushino-shi, 818-8502, Japan

  • Local Institution - 123

    Tsu, 514-8507, Japan

  • Local Institution - 124

    Fukui, 918-8503, Japan

  • Local Institution - 125

    Nagaoka, 940-8653, Japan

  • Local Institution - 126

    Hitachi, Ibaraki, 317-0077, Japan

  • Local Institution - 127

    Osaki-shi, 989-6183, Japan

  • Local Institution - 128

    Shinagawa-ku, Tokyo, 141-8625, Japan

  • Local Institution - 129

    Toyama, 939-8511, Japan

  • Local Institution - 130

    Kobe, 650-0017, Japan

  • Local Institution - 131

    Iruma-gun, Saitama, 3500495, Japan

  • Local Institution - 132

    Osaka, Osaka-shi, 545-8586, Japan

  • Local Institution - 133

    Hirosaki, 036-8203, Japan

  • Local Institution - 134

    Isehara City, Kanagawa, 259-1193, Japan

  • Local Institution - 135

    Kannonji, 769-1695, Japan

  • Local Institution - 136

    Okayama, 700-0013, Japan

  • Local Institution - 137

    Shizuoka, 420-8630, Japan

  • Local Institution - 138

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Local Institution - 139

    Abiko, 270-1168, Japan

  • Local Institution - 140

    Gifu, 500-8717, Japan

  • Local Institution - 141

    Kyoto, 602-8566, Japan

  • Local Institution - 142

    Kurume, 830-8543, Japan

  • Local Institution - 143

    Takatsuki, 569-1096, Japan

  • Local Institution - 144

    Kōriyama, 963-8501, Japan

  • Local Institution - 145

    Sakai, 591-8025, Japan

  • Local Institution - 146

    Sendai, 980-0021, Japan

  • Local Institution - 147

    Sapporo, 062-8618, Japan

  • Local Institution - 148

    Utsunomiya, 320-0003, Japan

  • Local Institution - 149

    Sunto-gun, 411-8611, Japan

  • Local Institution - 150

    Fujiidera, 538-0027, Japan

  • Local Institution - 151

    Hakodate, 040-8611, Japan

  • Local Institution - 152

    Aki-gun, 735-8585, Japan

  • Local Institution - 153

    Osaka, Osaka, 530-0052, Japan

  • Local Institution - 154

    Saga, 849-8501, Japan

  • Local Institution - 155

    Fukuoka, 815-8555, Japan

  • Local Institution - 156

    Okayama, Okayama-ken, 700-8558, Japan

  • Local Institution - 157

    Kawagoe, 350-8550, Japan

  • Local Institution - 158

    Kashiwa, 277-0871, Japan

  • Local Institution - 159

    Ōita, 870-0823, Japan

  • Local Institution - 160

    Hiroshima, 734-8530, Japan

  • Local Institution - 161

    Fukuoka, 810-0001, Japan

  • Local Institution - 162

    Iizuka, 820-8505, Japan

  • Local Institution - 163

    Kobe, 650-0015, Japan

  • Local Institution - 164

    Fukuoka, 812-0033, Japan

  • Local Institution - 165

    Kurume, 839-0809, Japan

  • Local Institution - 166

    Toshima-ku, 171-0021, Japan

  • Local Institution - 167

    Nagoya, 466-8560, Japan

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