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Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

A 24-month, Open-label, Prospective, Multicenter Interventional, Single-arm Study Assessing the Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Relapsing Multiple Sclerosis (RMS) Patients in China
CompletedPhase 4Relapsing MSNCT046679492024-000601-32

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Adjusted Annualized Relapse Rate (ARR) in Adult Group

Baseline to Month 24

GroupValueIntervalNumber analysed
Fingolimod > 18 Years0.018 relapses per participant-year0.006–0.06187

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Less Than 18 Years113 (27.3%)0
Greater Than or Equal to 18 Years8712 (13.8%)0
Overall9815 (15.3%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Adjusted Annualized Relapse Rate (ARR) in Adult Group

    Baseline to Month 24

    Disability progressionRelapsesBladder, bowel and sexual function

  • Change from baseline in Annualized relapse rate(ARR)

    Relapses

Other measures (10)

  • Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE)

    From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months

    Safety

  • Annualized Rate of the Number of New or Newly Enlarged T2 Lesions

    Baseline to end of treatment (up to Month 24)

    MRI lesions

  • Change From Baseline in Number of New or Newly Enlarged T2 Lesions

    Baseline up to Month 24

    MRI lesions

  • Change From Baseline in T2 Lesion Volume

    Baseline up to Month 24

    MRI lesions

  • Number of Gd-enhancing T1 Lesions Per Scan in Adult Group

    Baseline up to Month 24

    MRI lesions

  • Number of Gd-enhancing T1 Lesions

    Baseline up to Month 24

    MRI lesions

  • Change From Baseline in Gd-enhancing T1 Lesion Volume

    Baseline up to Month 24

    MRI lesions

  • Number of T1 Hypo-intense Lesions

    Baseline up to Month 24

    MRI lesions

  • Change From Baseline in T1 Hypo-intense Lesion Volume

    Baseline up to Month 24

    MRI lesions

  • 1.The number of Adverse events (AE) and serious adverse events

    Safety

Who could take part

Relapsing MS · 10 to 65

Inclusion Criteria: * Participant 10 to 17 years old inclusive with weight > 40kg. * Participant 18 to 65 years old inclusive; * Participants with relapsing multiple sclerosis * Participants never used fingolimod before enrollment * Subjects with Expanded Disability Status Scale (EDSS) score of 0 - 6.0 (inclusive) at Screening Exclusion Criteria: * Participants with certain cardiovascular conditions and/or findings in the screening ECG. * Diagnosis of macular edema during screening visit. * Increased risk for opportunistic infections * Participants with known active malignancies. * Participants who have been treated with teriflunomide within 3.5 months prior to baseline, except if active washout. * Participants with severe active infections, active chronic infection. * Participants with severe liver impairment. * Pregnant confirmed by a positive pregnancy test or nursing (lactating) women.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The main purpose of this study was to assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing multiple sclerosis (RMS)

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History

    1. Started

      Feb 2021

    2. Main results due

      Mar 2025

    3. Finished

      Mar 2025

    4. Results posted

      Aug 2025

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