NCT06396039Active, not recruitingPhase 4
A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis
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
Source: ClinicalTrials.gov · Last updated 16 Apr 2025
Brief summary (registry, in English)
The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 15 May 2024
- Primary completion date
- 29 Dec 2028
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Multiple sclerosis
- NCT number
- NCT06396039
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 84
- From 15 May 2024 to the primary completion date, 29 Dec 2028
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Participants must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
Lab values
- 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.
Other
- Participants must not have primary progressive MS at screening.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.