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New study tests ozanimod against standard drug for Steroid-Dependent UC

NCT ID NCT07271069

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how well ozanimod works compared to azathioprine for people with steroid-dependent ulcerative colitis in Japan. Researchers will review medical records of 150 adults to see which drug helps patients stop steroids and stay symptom-free. The goal is to find a better treatment option for this chronic condition.

What this could mean

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

Active substance
Ozanimod and azathioprine
What this could lead to
If ozanimod works better than azathioprine, it could offer a more effective way to control ulcerative colitis without long-term steroid use.
What could go wrong
This is an observational chart review, not a controlled trial, so results may be less reliable. The study is also limited to Japan, which may not apply to other populations.

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.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Who is studied

The study population will consist of adults diagnosed with ulcerative colitis (UC) who initiated ozanimod or azathioprine treatment after starting oral steroids and concomitant-use oral steroids in Japan

Ages

18 years and older

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: * Participants with Ulcerative Colitis (UC) provided written consent to participate in the study * Participants who are aged ≥ 18 years at the earlier date of either initiation of treatment with ozanimod or azathioprine or obtaining consent * Starting dose of oral steroid ≥ 30 mg/day (prednisolone equivalent) * Administration of ozanimod or azathioprine started after oral steroid administration, and ozanimod or azathioprine administered concomitantly with steroids (excluding patients who started oral steroids and ozanimod or azathioprine on the same day) * In the ozanimod group, patients with notable clinical symptoms due to the primary disease (rectal bleeding subscore ≥ 1 point or total PRO2 score ≥ 2 points) remained at the start of ozanimod administration * In the azathioprine group, patients who started azathioprine treatment after February 2019 Exclusion Criteria: * Participants with symptoms of UC with no change or increase in Patient-Reported Outcome 2 (PRO2) from the time of initiating oral steroid administration after 2 weeks of administration of ≥ 30 mg/day (prednisolone equivalent) of oral steroids * Participants with complications requiring continued steroid use (excluding topically acting steroids for inhalation or topical application) * Participants who participated in other clinical studies involving interventions during the observation period * Participants judged to be inappropriate for enrollment in this study by the investigator at each participating study site

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asahikawa Medical University

    RECRUITING

    Asahikawa, Hokkaido, 078-8510, Japan

  • Chiba University

    RECRUITING

    Chiba, Chiba, 263-8522, Japan

  • Ehime Prefectural Central Hospital

    NOT_YET_RECRUITING

    Matsuyama, Ehime, 790-0024, Japan

  • Fukuoka University Chikushi Hospital

    NOT_YET_RECRUITING

    Chikushino-shi, Fukuoka, 818-8502, Japan

  • Fukuoka University Chikushi Hospital

    RECRUITING

    Fukuoka, Fukuoka, 814-0180, Japan

  • Hamamatsu University School of Medicine

    RECRUITING

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hyogo Medical University

    RECRUITING

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Kagawa Prefectural Central Hospital

    NOT_YET_RECRUITING

    Takamatsu, Kagawa-ken, 760-8557, Japan

  • Kansai Medical University

    RECRUITING

    Hirakata, Osaka, 573-1010, Japan

  • Kyorin University School of Medicine

    RECRUITING

    Mitaka-shi, Tokyo, 181-8611, Japan

  • Mebix. Inc.

    RECRUITING

    Minato-ku, Tokyo, 1070052, Japan

  • Saga University

    NOT_YET_RECRUITING

    Saga, Saga-ken, 840-8502, Japan

  • Saitama Medical Center, Saitama Medical University

    RECRUITING

    Hidaka-shi, Saitama, 350-1298, Japan

  • Sapporo Higashi Tokushukai Hospital

    RECRUITING

    Sapporo, Hokkaido, 065-0033, Japan

  • Sapporo Medical University School of Medicine

    RECRUITING

    Hokkaidō, Japan

  • Toho University Sakura Hospital

    RECRUITING

    Sakura, Chiba, 285-8741, Japan

  • Tottori University

    NOT_YET_RECRUITING

    Tottori-shi, Tottori, 680-8550, Japan

  • Tsujinaka Hospital Kashiwanoha

    RECRUITING

    Kashiwa-shi, Chiba, 277-0871, Japan

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