Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
NCT ID: NCT01665144
Last Updated: 2024-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1651 participants
INTERVENTIONAL
2012-12-20
2023-03-31
Brief Summary
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Detailed Description
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Patients who were eligible to enter the Extension Part received open label siponimod.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Siponimod (BAF312)
Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312.
BAF312
0.25, 0.5, 1, and 2 mg film-coated tablets
Placebo
Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312.
Placebo
Film-coated tablets
Interventions
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BAF312
0.25, 0.5, 1, and 2 mg film-coated tablets
Placebo
Film-coated tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Phoenix, Arizona, United States
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Berkeley, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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Basalt, Colorado, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Englewood, Colorado, United States
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Fairfield, Connecticut, United States
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Delray Beach, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Ormond Beach, Florida, United States
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Port Charlotte, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Flossmoor, Illinois, United States
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Lenexa, Kansas, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Plymouth, Minnesota, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Freehold, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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New York, New York, United States
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Patchogue, New York, United States
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Stony Brook, New York, United States
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Charlotte, North Carolina, United States
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Akron, Ohio, United States
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Dayton, Ohio, United States
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Portland, Oregon, United States
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Springfield, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Camperdown, New South Wales, Australia
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Klagenfurt, , Austria
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Edegem, Antwerpen, Belgium
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Schwendi, , Germany
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Esztergom, HUN, Hungary
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Balassagyarmat, , Hungary
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Ramat Gan, , Israel
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Genova, GE, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Cefalù, PA, Italy
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Napoli, , Italy
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Tōon, Ehime, Japan
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Asahikawa, Hokkaido, Japan
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Morioka, Iwate, Japan
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Osaka, , Japan
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Riga, LV, Latvia
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Kaunas, LTU, Lithuania
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Hoorn, , Netherlands
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Sittard-Geleen, , Netherlands
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Tilburg, , Netherlands
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Grudziądz, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Constanța, , Romania
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Târgu Mureş, , Romania
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Timișoara, , Romania
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Barnaul, , Russia
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Kazan', , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Ufa, , Russia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Martin, , Slovakia
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Nitra, , Slovakia
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Prešov, , Slovakia
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Trenčín, , Slovakia
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Trnava, , Slovakia
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Bilbao, Basque Country, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Badalona, Catalonia, Spain
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Madrid, , Spain
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Valencia, , Spain
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Aarau, CH, Switzerland
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Lugano, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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Istanbul, TUR, Turkey (Türkiye)
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Altunizade, , Turkey (Türkiye)
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Haseki Istanbul, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Mecidiyekoy Istanbul, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
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Salford, Manchester, United Kingdom
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Headington, Oxfordshire, United Kingdom
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Sheffield, South Yorkshire, United Kingdom
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Bristol, , United Kingdom
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Glasgow, , United Kingdom
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Leeds, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2012-003056-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBAF312A2304
Identifier Type: -
Identifier Source: org_study_id
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