AzTrials
AzTrials

Relapsing Multiple SclerosisPhase 4NCT06396039

A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis

A Phase 4 study testing BMS-986374 in people with Relapsing Multiple Sclerosis, run by Bristol-Myers Squibb at 25 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
BMS-986374
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
25 sitesChina
Study dates
15 May 2024to 30 Mar 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants must have Multiple Sclerosis (MS) as diagnosed by the 2017 revision of the McDonald criteria.
  • Participants must be exhibiting a relapsing clinical course consistent with Relapsing Multiple Sclerosis (RMS) and history of brain MRI lesions consistent with MS.
  • Participants must have an EDSS score between 0 and 5.0 (both inclusive) at baseline.

Who cannot join

  • Participants must not have primary progressive MS at screening.
  • Participants must not be diagnosed with, or suspected to have neuromyelitis optica spectrum disorder (NMOSD) by clinical symptoms, MRI appearance, and/or supportive serologies according to international consensus criteria.28 A positive test for aquaporin-4 (AQP4) by history or at screening is exclusionary.
  • Participants must not have clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator.
  • Specific cardiac conditions are excluded, including history or presence of:.
  • Recent (within the past 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, New York Heart Association (NYHA) Class III/IV heart failure, or severe untreated sleep apnea.
  • Second-degree (Mobitz type II) atrioventricular (AV) block, third-degree AV block, sick sinus syndrome, or sino-atrial block unless participants have a pacemaker in place.
Show all 11Show fewer
  • Prolonged corrected QT interval by Fredericia's formula (QTcF; > 450 msec males and > 470 msec females), or participants at additional risk for QT prolongation.
  • Participants must not have diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 with hemoglobin A1c > 9%, or diabetic participants with significant comorbid conditions such as retinopathy or nephropathy.
  • Participants must not receive a live vaccine or a live-attenuated vaccine within 4 weeks prior to first dose or planning to receive a live vaccine or a live-attenuated vaccine during the study or within 28 days after discontinuation from study intervention.
  • Participants must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Local Institution - 0002

    Beijing, Beijing Municipality, 100070

  • Local Institution - 0009

    Beijing, 100034

  • Local Institution - 0005

    Changchun, Jilin, 130021

  • Local Institution - 0011

    Chengdu, Sichuan, 610041

  • Local Institution - 0025

    Fuzhou, 350001

  • Local Institution - 0012

    Guangzhou, Guangdong, 510080

  • Local Institution - 0022

    Guangzhou, Guangdong, 510260

  • Local Institution - 0010

    Guiyang, 550000

  • Local Institution - 0019

    Hangzhou, Zhejiang, 310016

  • Local Institution - 0006

    Harbin, Heilongjiang, 150086

  • Local Institution - 0013

    Hohhot, 10017

  • Local Institution - 0024

    Kunming, Yunnan, 650032

  • Local Institution - 0003

    Nanchang, Jiangxi, 330006

  • Local Institution - 0016

    Shanghai, Shanghai Municipality, 200030

  • Local Institution - 0014

    Shanghai, 200127

  • Local Institution - 0021

    Shenyang, 110004

  • Local Institution - 0008

    Shenzhen, Guangdong, 518036

  • Local Institution - 0004

    Shijiazhuang, Hebei, 050000

  • Local Institution - 0015

    Taiyuan, Shan1xi, 030001

  • Local Institution - 0001

    Tianjin, 300052

  • Local Institution - 0023

    Ürümqi, Shan1xi, 830054

  • Local Institution - 0017

    Wenzhou, Zhejiang, 32500

  • Local Institution - 0007

    Wuhan, Hubei, 430030

  • Local Institution - 0020

    Xianyang, 712000

  • Local Institution - 0018

    Zhengzhou, Henan, 450004

Other trials in China

About this study

Official title: A Phase 4, Multicenter, Single-arm, Open-label Study to Evaluate the Effectiveness and Safety of Oral Ozanimod for Relapsing Multiple Sclerosis (RMS) in Chinese Participants

The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.

Being tested
BMS-986374

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986374Drug

    Also called Ozanimod

    Specified dose on specified days.

Study groups in NCT06396039
Study groupRoleWhat they receive
Administration of BMS-986374ExperimentalNot described
Receives: Drug: BMS-986374

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized relapse rate (ARR) over 36 months

    Measured: Up to 3 years

Secondary outcomes (20)

  1. Annualized relapse rate (ARR) over 12 months and 24 months

    Measured: Up to 2 years

  2. The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36

    Measured: Up to 3 years

  3. The cumulative number of GdE brain MRI lesions at Months 12, 24, and 36

    Measured: Up to 3 years

  4. Proportion of participants who are new or enlarging hyperintense T2 lesion free at Months 12, 24, and 36

    Measured: Up to 3 years

  5. Proportion of participants who are GdE lesion-free at Months 12, 24, and 36

    Measured: Up to 3 years

  6. Proportion of participants with adverse events (AEs)

    Measured: Up to 40 months

  7. Proportion of participants with serious adverse events (SAEs)

    Measured: Up to 40 months

  8. Proportion of participants with AEs leading to discontinuation of study treatment

    Measured: Up to 3 years

  9. Proportion of participants with laboratory abnormalities

    Measured: Up to 40 months

  10. Proportion of participants with vital sign abnormalities

    Measured: Up to 40 months

  11. Proportion of participants with electrocardiogram (ECG) abnormalities

    Measured: Up to 40 months

  12. Proportion of participants with physical examination abnormalities

    Measured: Up to 40 months

  13. Proportion of participants with serious or opportunistic infections

    Measured: Up to 40 months

  14. Proportion of participants with malignancy

    Measured: Up to 40 months

  15. Proportion of participants with bradycardia and heart condition abnormalities

    Measured: Up to 40 months

  16. Proportion of participants with pulmonary toxicity

    Measured: Up to 40 months

  17. Proportion of participants with macular edema

    Measured: Up to 40 months

  18. Proportion of participants with hepatotoxicity

    Measured: Up to 40 months

  19. Proportion of participants with posterior reversible encephalopathy syndrome

    Measured: Up to 40 months

  20. Proportion of participants with progressive multifocal leukoencephalopathy

    Measured: Up to 40 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start15 May 2024
  3. Primary completion29 Dec 2028 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06396039
Sponsor's protocol ID
IM047-1096
Status last verified
Apr 2025
First submitted
29 Apr 2024
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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-andresearch/disclosure-commitment.html

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BMS-986374 in people with Relapsing Multiple Sclerosis, run by Bristol-Myers Squibb at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized relapse rate (ARR) over 36 months (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06396039.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in