Phase 4
N=98
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
Relapsing Multiple Sclerosis (RMS)
Bottom Line
View on ClinicalTrials.gov: NCT04667949 ↗Enrolled (actual)
98
Serious AEs
15.3%
Results posted
Aug 2025
Primary outcome: Primary: Adjusted Annualized Relapse Rate (ARR) in Adult Group — 0.018 relapses per participant-year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fingolimod 0.5mg (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Annualized Relapse Rate (ARR) in Adult Group |
0.018 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) |
11; 86; 10; 81; 3; 12 | — |
| SECONDARY Annualized Rate of the Number of New or Newly Enlarged T2 Lesions |
1.316 | — |
| SECONDARY Change From Baseline in Number of New or Newly Enlarged T2 Lesions |
1.8; 1.8; 2.1; 2.4 | — |
| SECONDARY Change From Baseline in T2 Lesion Volume |
0.6140; 0.3930; -1.6736; 0.4065 | — |
| SECONDARY Number of Gd-enhancing T1 Lesions Per Scan in Adult Group |
0.376 | — |
| SECONDARY Number of Gd-enhancing T1 Lesions |
0.4; 0.4; 0; 0.4 | — |
| SECONDARY Change From Baseline in Gd-enhancing T1 Lesion Volume |
-56.0; 0.00; -56.0; 0.00 | — |
| SECONDARY Number of T1 Hypo-intense Lesions |
14.6; 17.0; 13.4; 16.7 | — |
| SECONDARY Change From Baseline in T1 Hypo-intense Lesion Volume |
-77.500; 44.000; -641.415; 187.100 | — |
Summary
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)
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04667949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.