A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

NCT05644665 | Terminated Phase 3

• 1 other identifier: IM047-010
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 51

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. The main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with clinical remission as measured by the 3-component Mayo Score

  At week 10

Secondary Outcomes (14)

• Proportion of participants with clinical remission as measured by the 3-component Mayo Score

  At week 52

• Proportion of participants with clinical response as measured by the 3-component Mayo Score

  At week 10 and at week 52

• Proportion of participants with endoscopic improvement

  At week 10 and at week 52

• Proportion of participants achieving histologic remission

  At week 10 and at week 52

• Proportion of participants with mucosal healing

  At week 10 and at week 52

Study Arms (2)

Arm A: Ozanimod

EXPERIMENTAL

Drug: Ozanimod

Arm B: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ozanimod DRUG

Specified dose on specified days

Also known as: BMS-986374

Arm A: Ozanimod

Placebo DRUG

Specified dose on specified days

Arm B: Placebo

Eligibility Criteria

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

You may qualify if:

• Main Study:
• Eligible participants must be Chinese.
• Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration.
• Open-label Extension Period:
• Participants who have completed the Week 10 Visit and are non-responders at Week 10.
• Participants who have completed the Induction Period and entered the Maintenance Period experienced disease relapse during the Maintenance Period, or who have completed the Maintenance Period at Week 52.

You may not qualify if:

• Main Study and Open-label Extension Period:
• Participant has severe extensive colitis, diagnosis of CD, indeterminate colitis, presence or history of a fistula consistent with CD, microscopic colitis, radiation colitis, or ischemic colitis.
• Open-label Extension Period:
• Participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the Induction Period or Maintenance Period.
• Participant has clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea were observed during the Induction Period or Maintenance Period.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (51)

Local Institution - 0012

Hefei, Anhui, 230071, China

Location

Local Institution - 0013

Wuhu, Anhui, 241001, China

Location

Local Institution - 0052

Beijing, Beijing Municipality, 102206, China

Location

Local Institution - 0050

Chongqing, Chongqing Municipality, 400014, China

Location

Local Institution - 0011

Xiamen, Fujian, 361004, China

Location

Local Institution - 0020

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0036

Guangzhou, Guangdong, 510180, China

Location

Local Institution - 0028

Guangzhou, Guangdong, 510280, China

Location

Local Institution - 0019

Guangzhou, Guangdong, 510515, China

Location

Local Institution - 0008

Guangzhou, Guangdong, 510655, China

Location

Local Institution - 0004

Zhanjiang, Guangdong, 524004, China

Location

Local Institution - 0051

Guilin, Guangxi, 541001, China

Location

Local Institution - 0007

Shijiazhuang, Hebei, 050000, China

Location

Local Institution - 0006

Shijiazhuang, Hebei, 050011, China

Location

Local Institution - 0040

Wuhan, Hubei, 430022, China

Location

Local Institution - 0037

Wuhan, Hubei, 430030, China

Location

Local Institution - 0033

Wuhan, HUB, 430060, China

Location

Local Institution - 0027

Changsha, Hunan, 410008, China

Location

Local Institution - 0022

Changsha, Hunan, 410013, China

Location

Local Institution - 0061

Changzhou, Jiangsu, 0, China

Location

Local Institution - 0046

Changzhou, Jiangsu, 213003, China

Location

Local Institution - 0024

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0045

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0018

Suzhou, Jiangsu, 215004, China

Location

Local Institution - 0009

Suzhou, Jiangsu, 215006, China

Location

Local Institution - 0044

Wuxi, Jiangsu, 214023, China

Location

Local Institution - 0042

Zhenjiang, Jiangsu, 212000, China

Location

Local Institution - 0010

Shenyang, Liaoning, 110004, China

Location

Local Institution - 0029

Xi'an, Shaanxi, 710032, China

Location

Local Institution - 0026

Xi'an, Shaanxi, 710038, China

Location

Local Institution - 0039

Jinan, Shandong, 250014, China

Location

Local Institution - 0035

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0041

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0034

Shanghai, Shanghai Municipality, 200092, China

Location

Local Institution - 0015

Taiyuan, Shanxi, 030001, China

Location

Local Institution - 0032

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0025

Chengdu, Sichuan, 610072, China

Location

Local Institution - 0031

Tianjin, Tianjin Municipality, 300052, China

Location

Local Institution - 0047

Tianjin, Tianjin Municipality, 300121, China

Location

Local Institution - 0049

Kunming, Yunnan, 650034, China

Location

Local Institution - 0030

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0048

Fuzhou, 350005, China

Location

Local Institution - 0053

Shanghai, 200120, China

Location

Local Institution - 0054

Changhua County, Changhua, 50006, Taiwan

Location

Local Institution - 0060

Taipei City, Taipei, 114, Taiwan

Location

Local Institution - 0058

New Taipei City, 235, Taiwan

Location

Local Institution - 0001

Taichung, 40447, Taiwan

Location

Local Institution - 0059

Taichung, 407, Taiwan

Location

Local Institution - 0056

Taipei, 10002, Taiwan

Location

Local Institution - 0057

Taipei, 11217, Taiwan

Location

Local Institution - 0055

Taoyuan District, 333, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: December 9, 2022
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

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

Locations

TW (8); CN (43)