Phase 3 N=1,651 Randomized Double-blind Treatment

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

Secondary Progressive Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT01665144 ↗

Enrolled (actual)

1,651

Serious AEs

28.1%

Results posted

Oct 2018

Primary outcome: Primary: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) — 26.3; 31.7 Percentage of participants — p=0.0134

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BAF312 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)	26.3; 31.7	0.0134 sig
SECONDARY Percentage of Participants With 3-month Confirmed Worsening in T25W of at Least 20% From Baseline	39.7; 41.4	0.4398
SECONDARY Change From Baseline in T2 Lesion Volume	204.9; 818.0; 162.9; 940.4; 183.9; 879.2	<0.0001 sig
SECONDARY Percentage of Participants With 6-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)	19.9; 25.5	0.0058 sig
SECONDARY Annualized Relapse Rate (ARR) for Confirmed Relapses	0.071; 0.160	<0.0001 sig
SECONDARY Percentage of Participants With First Relapse Events as Measured by Time to First Confirmed Relapse	10.7; 18.9	<0.0001 sig
SECONDARY Percentage of Patients With Relapse (Confirmed Relapse and Any Relapse)	16.7; 26.0; 10.3; 18.7	—
SECONDARY Change From Baseline in MSWS-12 Converted Score	1.53; 3.36; 4.16; 5.38	0.0764
SECONDARY Number of T1 Gd-enhancing Lesions Per Patient Per Scan	0.080; 0.640; 0.074; 0.418	<0.0001 sig
SECONDARY Number of New or Enlarging T2 Lesions Per Patient Per Year	1.003; 3.776; 0.489; 3.437	<0.0001 sig
SECONDARY Percent Brain Volume Change (PBVC) Relative to Baseline	-0.283; -0.458; -0.711; -0.839	<0.0001 sig
SECONDARY Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of SPMS Patients With/Without Superimposed Relapses	190; 101; 98; 72; 237; 122	—
SECONDARY Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Rapidly and Not Rapidly Evolving Patients	82; 60; 206; 113	—
SECONDARY Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Patients With and Without Moderate/Severe Disease Course	232; 141; 56; 32	—

Summary

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

Eligibility 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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01665144). 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.