Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069 | Recruiting FDA Drug

• 1 other identifier: IM047-1120
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving steroid-free symptomatic remission

  Week 12; Weeks 24 and 52

Secondary Outcomes (5)

• Oral steroid dose prescribed

  Week 12; Weeks 24 and 52

• Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation

  Weeks 24 and 52

• Steroid-free maintenance period duration

  Up to Week 52

• Time to achieving steroid-free status

  Up to Week 52

• Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs)

  Up to Week 52

Study Arms (2)

Group 1

Participants with ulcerative colitis receiving ozanimod

Drug: Ozanimod

Group 2

Participants with ulcerative colitis receiving azathioprine

Drug: Azathioprine

Interventions

Ozanimod DRUG

According to the product label

Group 1

Azathioprine DRUG

According to the product label

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (17)

Chiba University

Chiba, Chiba, 263-8522, Japan

RECRUITING

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, 277-0871, Japan

RECRUITING

Toho University Sakura Hospital

Sakura, Chiba, 285-8741, Japan

RECRUITING

Ehime Prefectural Central Hospital

Matsuyama, Ehime, 790-0024, Japan

NOT YET RECRUITING

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, 818-8502, Japan

NOT YET RECRUITING

Fukuoka University Chikushi Hospital

Fukuoka, Fukuoka, 814-0180, Japan

RECRUITING

Asahikawa Medical University

Asahikawa, Hokkaido, 078-8510, Japan

RECRUITING

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, 065-0033, Japan

RECRUITING

Hyogo Medical University

Nishinomiya, Hyōgo, 663-8501, Japan

RECRUITING

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, 760-8557, Japan

NOT YET RECRUITING

Kansai Medical University

Hirakata, Osaka, 573-1010, Japan

RECRUITING

Saga University

Saga, Saga-ken, 840-8502, Japan

NOT YET RECRUITING

Saitama Medical Center, Saitama Medical University

Hidaka-shi, Saitama, 350-1298, Japan

RECRUITING

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Kyorin University School of Medicine

Mitaka-shi, Tokyo, 181-8611, Japan

RECRUITING

Tottori University

Tottori-shi, Tottori, 680-8550, Japan

NOT YET RECRUITING

Sapporo Medical University School of Medicine

Hokkaidō, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod; Azathioprine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 8, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (17)