Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study

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

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: Ozanimod; Drug: Azathioprine

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Japan
  • Hokkaidō, Japan
    • Recruiting
    • Sapporo Medical University School of Medicine
  • Chiba
    • Chiba, Chiba, Japan, 263-8522
      • Recruiting
      • Chiba University
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Recruiting
      • Tsujinaka Hospital Kashiwanoha
    • Sakura, Chiba, Japan, 285-8741
      • Recruiting
      • Toho University Sakura Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 790-0024
      • Not yet recruiting
      • Ehime Prefectural Central Hospital
  • Fukuoka
    • Chikushino-shi, Fukuoka, Japan, 818-8502
      • Not yet recruiting
      • Fukuoka University Chikushi Hospital
    • Fukuoka, Fukuoka, Japan, 814-0180
      • Recruiting
      • Fukuoka University Chikushi Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 078-8510
      • Recruiting
      • Asahikawa Medical University
    • Sapporo, Hokkaido, Japan, 065-0033
      • Recruiting
      • Sapporo Higashi Tokushukai Hospital
  • Hyōgo
    • Nishinomiya, Hyōgo, Japan, 663-8501
      • Recruiting
      • Hyogo Medical University
  • Kagawa-ken
    • Takamatsu, Kagawa-ken, Japan, 760-8557
      • Not yet recruiting
      • Kagawa Prefectural Central Hospital
  • Osaka
    • Hirakata, Osaka, Japan, 573-1010
      • Recruiting
      • Kansai Medical University
  • Saga-ken
    • Saga, Saga-ken, Japan, 840-8502
      • Not yet recruiting
      • Saga University
  • Saitama
    • Hidaka-shi, Saitama, Japan, 350-1298
      • Recruiting
      • Saitama Medical Center, Saitama Medical University
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Recruiting
      • Hamamatsu University School of Medicine
  • Tokyo
    • Minato-ku, Tokyo, Japan, 1070052
      • Recruiting
      • Mebix. Inc.
      • Contact: Takao Fujii, Site 0001; Phone Number: +81-73-441-0875
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Recruiting
      • Kyorin University School of Medicine
  • Tottori
    • Tottori-shi, Tottori, Japan, 680-8550
      • Not yet recruiting
      • Tottori University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Participants with ulcerative colitis receiving ozanimod	Drug: Ozanimod; According to the product label
Group 2; Participants with ulcerative colitis receiving azathioprine	Drug: Azathioprine; According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving steroid-free symptomatic remission	Week 12; Weeks 24 and 52

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis (UC)
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Nucleosides; Thionucleosides; Mercaptopurine; Azathioprine; ozanimod
• Other Study ID Numbers: IM047-1120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes