Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222397

Enrollment

1530

Registered

2014-02-19

Start date

2014-06-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Progressive Multiple Sclerosis

Interventions

investigational material(s) Generic name etc : BAF312 INN of investigational material : Siponimod Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Prior history of relapsing remitting MS *SPMS defined as progressive increase of disability over at least 6 months *EDSS score of 3.0 to 6.5 *No relapse of corticosteroid treatment within 3 months

Exclusion criteria

Exclusion criteria: *Women of child bearing potential must use reliable forms of contraception *Diagnosis of Macular edema during screening period *Any medically unstable condition determined by investigator *Unable to undergo MRI scans *Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply

Design outcomes

Primary

Measure	Time frame
The delay in time to confirmed disability progression as measured by EDSS.	—

Secondary

Measure	Time frame
Efficacy of BAF312 relative to placebo in confirmed worsening of 25 foot walk test Efficacy of BAF312 relative to placebo in reducing the increase in T2 lesion volume The delay in time to confirmed disability progression as measured by EDSS.	—

Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, United Kingdom, United States

Contacts

Public ContactHideki Maruyama

Novartis Pharma K. K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026