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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04667949
Collaborator
(none)
100
13
1
46.2
7.7
0.2

Study Details

Study Description

Brief Summary

To assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing relapsing multiple sclerosis (RMS)

Condition or Disease Intervention/Treatment Phase
  • Drug: Fingolimod 0.5mg
Phase 4

Detailed Description

This is a 24-month, open-label, multicenter, interventional, single-arm study to collect efficacy and, safety of oral fingolimod 0.5 mg/day in approximately 100 relapsing multiple sclerosis (RMS) subjects in China.

The study will consist of three Phases:

Screening (up to 1 month): After signing informed consent, subjects will enter a Screening Phase to determine eligibility according to inclusion and exclusion criteria.

Treatment Period (24 months): On visit Day 1, all eligibility criteria will be confirmed, including a pre-dose ECG and vital signs. The first dose of study drug will be taken in the clinic on Day 1 and the subject will be monitored for 6 hours after the first dose administration before discharge. Participants will return to site for evaluation at month 1 and then every three months until the end of treatment up to 24 months.

Follow Up (2 months): Subjects who completed Treatment Period or discontinued from treatment will return for the Follow-up visit 2 months after the last dose of study drug.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 20, 2021
Anticipated Primary Completion Date :
Oct 15, 2024
Anticipated Study Completion Date :
Dec 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fingolimod

Fingolimod 0.5 mg capsule taken orally once daily

Drug: Fingolimod 0.5mg
Subjects will receive fingolimod 0.5mg capsule QD up to month 24
Other Names:
  • FTY720
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Annualized relapse rate(ARR) [Baseline to Month 24]

      A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A confirmed relapse by Treating Physician must be confirmed within 7 days of onset of symptoms and accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS.The EDSS is an ordinal scale used for assessing neurologic impairment based on an exam consisting of seven functional systems (FSs)which are scored from 0 to 10 (death from MS) and an ambulation score that are combined to determine the EDSS steps. The higher score means the worsening of neurological status.

    Secondary Outcome Measures

    1. The number of Adverse events (AE) and serious adverse events (SAE) [Baseline up to Month 26]

      Adverse events will be collected at each visit throughout the trial including a 2 month follow up period. Results from safety assessments may be recorded as adverse events if determined by the investigator to meet requirements of clinical significance and meeting definition of adverse event

    2. Change from baseline in T1 hypo-intense lesion volume [Baseline up to Month 24]

      T1 hypo-intense lesions as measured by Magnetic Resonance Imaging (MRI)

    3. Change from baseline in T2 lesion-new/newly enhancing lesion volume [Baseline up to Month 24]

      T2 lesion-new/newly enhancing lesions as measured by MRI

    4. Change from baseline in Gd-enhancing T1 lesion volume [Baseline up to Month 24]

      Gd-enhancing T1 lesions as measured by MRI

    5. Change from baseline in number of T1 hypo-intense lesions [Baseline up to Month 24]

      Number of T1 hypo-intense lesions as measured by MRI

    6. Change from baseline in number of T2 lesions-new/newly enhancing lesions [Baseline up to Month 24]

      Number of T2 lesions-new/newly enhancing lesions as measured by MRI

    7. Change from baseline in number of Gd-enhancing T1 lesions [Baseline up to Month 24]

      Number of Gd-enhancing T1 lesions as measured by MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Other protocol-specified inclusion or exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Beijing Beijing China 100000
    2 Novartis Investigative Site Beijing Beijing China
    3 Novartis Investigative Site Guangzhou Guangdong China 510623
    4 Novartis Investigative Site Guangzhou Guangdong China 510630
    5 Novartis Investigative Site Zhengzhou Henan China 450052
    6 Novartis Investigative Site Wuhan Hubei China 430030
    7 Novartis Investigative Site Suzhou Jiangsu China 215004
    8 Novartis Investigative Site Changchun Jilin China 130021
    9 Novartis Investigative Site Chengdu Sichuan China 610041
    10 Novartis Investigative Site Wenzhou Zhejiang China 325000
    11 Novartis Investigative Site Beijing China 100028
    12 Novartis Investigative Site Guang Zhou China 510260
    13 Novartis Investigative Site Shanghai China 200040

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04667949
    Other Study ID Numbers:
    • CFTY720D2419
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2022