Clinical trial NCT01665144: Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Progressive Multiple Sclerosis
Keywords: Secondary Progressive Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 1651
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: This study had two parts, a Core Part and an Extension Part. The Core Part of the study was a randomized, multicenter, double-blind, placebo-controlled parallel-group study in patients with secondary progressive multiple sclerosis (SPMS). Eligible patients were randomized (2:1) to receive either siponimod or placebo. The duration of the Core Part of the study was variable for each patient, given that this was an event-driven study and terminated when a pre-defined number of confirmed disability progression (CDP) events had occurred irrespective of duration of individual patient participation. Patients who had 6-month CDP during the Treatment Epoch of the Core Part were provided with options that included starting treatment with open label siponimod as rescue medication.

Patients who were eligible to enter the Extension Part received open label siponimod.

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

Primary outcomes:
measure: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, every 3 month up to the maximum of approximately 3 years
Secondary outcomes:
measure: Percentage of Participants With 3-month Confirmed Worsening in T25W of at Least 20% From Baseline
timeFrame: Baseline, every 3 months up to the maximum of approximately 3 years
measure: Change From Baseline in T2 Lesion Volume
timeFrame: Baseline, Month 12 and Month 24
measure: Percentage of Participants With 6-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, every 3 months up to the maximum of approximately 3 years
measure: Annualized Relapse Rate (ARR) for Confirmed Relapses
timeFrame: Up to maximum approximately 3 years
measure: Percentage of Participants With First Relapse Events as Measured by Time to First Confirmed Relapse
timeFrame: Up to maximum approximately 3 years
measure: Percentage of Patients With Relapse (Confirmed Relapse and Any Relapse)
timeFrame: Up to maximum approximately 3 years
measure: Change From Baseline in MSWS-12 Converted Score
timeFrame: Baseline, Month 12 and Month 24
measure: Number of T1 Gd-enhancing Lesions Per Patient Per Scan
timeFrame: Baseline, Month 12 and Month 24
measure: Number of New or Enlarging T2 Lesions Per Patient Per Year
timeFrame: Baseline, Month 12 and Month 24
measure: Percent Brain Volume Change (PBVC) Relative to Baseline
timeFrame: Baseline, Month 12 and Month 24
measure: Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of SPMS Patients With/Without Superimposed Relapses
timeFrame: Baseline, every 3 months up to the maximum of approximately 3 years
measure: Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Rapidly and Not Rapidly Evolving Patients
timeFrame: Baseline, every 3 months up to the maximum of approximately 3 years
measure: Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Patients With and Without Moderate/Severe Disease Course
timeFrame: Baseline, every 3 months up to the maximum of approximately 3 years
Other outcomes:
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country: United States
facility: Novartis Investigative Site
state: Arizona
city: Berkeley
country: United States
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city: Los Angeles
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city: Berg
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city: Berlin
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facility: Novartis Investigative Site
city: Bielefeld
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country: Hungary
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state: HUN
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city: Budapest
country: Hungary
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facility: Novartis Investigative Site
city: Budapest
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country: Italy
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country: Spain
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country: Sweden
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country: Sweden
facility: Novartis Investigative Site
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country: Switzerland
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country: Switzerland
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country: Turkey
facility: Novartis Investigative Site
city: Trabzon
country: Turkey
facility: Novartis Investigative Site
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
state: Manchester
city: Headington
country: United Kingdom
facility: Novartis Investigative Site
state: Oxfordshire
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
state: South Yorkshire
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Gold R, Piani-Meier D, Kappos L, Bar-Or A, Vermersch P, Giovannoni G, Fox RJ, Arnold DL, Benedict RHB, Penner IK, Rouyrre N, Kilaru A, Karlsson G, Ritter S, Dahlke F, Hach T, Cree BAC. Siponimod vs placebo in active secondary progressive multiple sclerosis: a post hoc analysis from the phase 3 EXPAND study. J Neurol. 2022 Sep;269(9):5093-5104. doi: 10.1007/s00415-022-11166-z. Epub 2022 May 31.
citation: Cree BA, Arnold DL, Fox RJ, Gold R, Vermersch P, Benedict RH, Bar-Or A, Piani-Meier D, Rouyrre N, Ritter S, Kilaru A, Karlsson G, Giovannoni G, Kappos L. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 Sep;28(10):1591-1605. doi: 10.1177/13524585221083194. Epub 2022 Apr 5.
citation: Leppert D, Kropshofer H, Haring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4.
citation: Arnold DL, Piani-Meier D, Bar-Or A, Benedict RH, Cree BA, Giovannoni G, Gold R, Vermersch P, Arnould S, Dahlke F, Hach T, Ritter S, Karlsson G, Kappos L, Fox RJ; EXPAND Clinical Investigators. Effect of siponimod on magnetic resonance imaging measures of neurodegeneration and myelination in secondary progressive multiple sclerosis: Gray matter atrophy and magnetization transfer ratio analyses from the EXPAND phase 3 trial. Mult Scler. 2022 Sep;28(10):1526-1540. doi: 10.1177/13524585221076717. Epub 2022 Mar 9.
citation: Schur N, Gudala K, Vudumula U, Vadapalle S, Bhadhuri A, Casanova A, Adlard N, Schwenkglenks M. Cost Effectiveness and Budget Impact of Siponimod Compared to Interferon Beta-1a in the Treatment of Adult Patients with Secondary Progressive Multiple Sclerosis with Active Disease in Switzerland. Pharmacoeconomics. 2021 May;39(5):563-577. doi: 10.1007/s40273-021-01023-8. Epub 2021 Apr 1.
citation: Benedict RHB, Tomic D, Cree BA, Fox R, Giovannoni G, Bar-Or A, Gold R, Vermersch P, Pohlmann H, Wright I, Karlsson G, Dahlke F, Wolf C, Kappos L. Siponimod and Cognition in Secondary Progressive Multiple Sclerosis: EXPAND Secondary Analyses. Neurology. 2021 Jan 19;96(3):e376-e386. doi: 10.1212/WNL.0000000000011275. Epub 2020 Dec 16.
citation: Kappos L, Bar-Or A, Cree BAC, Fox RJ, Giovannoni G, Gold R, Vermersch P, Arnold DL, Arnould S, Scherz T, Wolf C, Wallstrom E, Dahlke F; EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018 Mar 31;391(10127):1263-1273. doi: 10.1016/S0140-6736(18)30475-6. Epub 2018 Mar 23.