A Study to Evaluate Efficacy and Long-term Safety of Oral... | NCT05644665

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business objectives have changed

Expanded Access Info

Start Date

Dec 9, 2022Actual

Primary Completion Date

Mar 7, 2025Actual

Completion Date

Mar 7, 2025Actual

First Submitted Date

Dec 1, 2022

First Submission Date that Met QC Criteria

Dec 1, 2022

First Posted Date

Dec 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2025

Last Update Posted Date

Mar 26, 2025Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Label	Type	Description	Intervention Names
Arm A: Ozanimod	Experimental		Drug: Ozanimod
Arm B: Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ozanimod	Drug	Specified dose on specified days	Arm A: Ozanimod	BMS-986374

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of participants with clinical remission as measured by the 3-component Mayo Score		At week 10

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0012		Hefei	Anhui	230071	China
Local Institution - 0013

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See Plan Description

Access Criteria

See Plan Description

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases