A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312(CBAF312A2304)
- Conditions
- MSsecondary progressive MS10029305
- Registration Number
- NL-OMON53018
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Core part:
• 18 to 60 years (inclusive).
• History of relapsing-remitting MS according to the 2010 Revised McDonald
criteria.
• Secondary progressive course of MS.
• EDSS score of 3.0 to 6.5 (inclusive).
• Documented EDSS progression in the 2 years prior to study of >=1 point for
patients with EDSS <6.0 at baseline, and >=0.5 point for patients with EDSS >=6.0
at baseline. Should documented EDSS scores not be available, a written summary
of the clinical evidence of disability progression in the previous 2 years, and
retrospective assessment of EDSS score from data up to 2 years prior to
screening must be submitted for central review.
• No evidence of relapse or corticosteroid treatment within 3 months prior to
randomization., Patients who completed the Core Part on:
* double-blind treatment
* open-label BAF312
* abbreviated schedule of assessments (with the exception of patients with
BAF312-related AE or SAE)
are eligible to enter the extension part.
• Active chronic disease (or stable but treated with immune therapy) of the
immune system other than MS.
• Diagnosis of macular edema during pre-randomization phase (patients with a
history of macular edema will be allowed to enter the study provided that they
do not have macular edema at the ophthalmic examination at the Screening Visit).
• Negative for varicella-zoster virus IgG antibodies at Screening.
• Live or live-attenuated vaccines within 2 months prior to randomization.
• Have been treated with: BAF312, fingolimod within 2 months (M) or for more
than 6 M, intravenous immunoglobulin within 2 M, dimethyl fumarate within 2 M,
natalizumab within 6 M, immunosuppressive/chemotherapeutic medications within 6
M, cyclophosphamide within 12 M, rituximab, ofatumumab, ocrelizumab, cladribine
within 24 M, mitoxantrone during previous 24 M or evidence of cardiotoxicity
following mitoxantrone or a cumulative life-time dose of more than 60 mg/m2,
teriflunomide within 2Y (unless teriflunomide plasma concentration is zero or
without relevant biological significance) OR within 2W following successful
accelerated elimination procedure as described in the product label
• Abnormalities in the Suicidal Ideation section of the eC-SSRS (see protocol
for details)
• Homozygosity for CYP2C9*3 (will be tested at Screening), or refusal to test
for CYP2C9*3 haplotype.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Expanded Disability Status Score (EDSS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Timed 25-Foot walk (T25W), Nine Hole Peg Test (9-HPT), Paced Auditory Serial<br /><br>Addition Test (PASAT), MS Relapse, MRI, Symbol Digital Modalities Test (SDMT),<br /><br>Brief Visuospatial Memory Test-Revised (BVMT-R), Low Contract Visual Acuity<br /><br>(LCVA), adverse events, questionnaires QoL and Colombia Suicide Severity<br /><br>Rating, PK, pharmacogenomics (optional), biomarkers.</p><br>