Phase 2
N=184
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01185821 ↗Enrolled (actual)
184
Serious AEs
16.9%
Results posted
Dec 2017
Primary outcome: Primary: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. — 4; 7; 6; 6 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BAF312 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. |
4; 7; 6; 6; 8; 30 | — |
| PRIMARY Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) |
5; 2; 5; 2; 4; 3 | — |
| PRIMARY Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) |
4 | — |
| PRIMARY Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) |
1; 3; 2; 1; 1; 8 | — |
| PRIMARY Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) |
5; 0; 4; 2; 4; 5 | — |
| PRIMARY Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) |
1; 0; 1; 0; 1 | — |
| SECONDARY Number of Relapses in One Year - Annualized Relapse Rates for Overall Extension Study (ARR) (Extension Set) |
0.18; 0.15; 0.16; 0.19; 0.22 | — |
| SECONDARY Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set) |
58.1; 57.7; 58.1; 44.8; 66.0; 32.3 | — |
| SECONDARY Percentage of Participants Free of Confirmed Disability Progression in Extension Study (Extension Set) |
72.3; 82.4; 84.8; 81.4; 78.6 | — |
Summary
This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population
Eligibility Criteria
Inclusion Criteria
- Patients completed the core study BAF312A2201
- Written informed consent provided before any assessment of the extension study
- Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
Exclusion Criteria
- Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
- Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
- Active infections
Data sourced from ClinicalTrials.gov (NCT01185821). 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.