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

NCT01665144 | Completed Phase 3 Results

• 2 other identifiers: CBAF312A23042012-003056-36
• Study Type: interventional
• Target: 1,651
• Locations: 29 countries
• Sites: 283

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).

Conditions

Secondary Progressive Multiple Sclerosis

Keywords

Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

  The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS steps, ranging from 0 (normal) to 10 (death due to MS). 3-month confirmed disability progression is defined as an increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5 sustained for at least 3 months.

  Baseline, every 3 month up to the maximum of approximately 3 years

Secondary Outcomes (13)

• Percentage of Participants With 3-month Confirmed Worsening in T25W of at Least 20% From Baseline

  Baseline, every 3 months up to the maximum of approximately 3 years

• Change From Baseline in T2 Lesion Volume

  Baseline, Month 12 and Month 24

• Percentage of Participants With 6-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

  Baseline, every 3 months up to the maximum of approximately 3 years

• Annualized Relapse Rate (ARR) for Confirmed Relapses

  Up to maximum approximately 3 years

• Percentage of Participants With First Relapse Events as Measured by Time to First Confirmed Relapse

  Up to maximum approximately 3 years

Study Arms (2)

Siponimod (BAF312)

EXPERIMENTAL

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.

Drug: BAF312

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

BAF312 DRUG

0.25, 0.5, 1, and 2 mg film-coated tablets

Siponimod (BAF312)

Placebo DRUG

Film-coated tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (290)

Novartis Investigative Site

Phoenix, Arizona, 85032, United States

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Berkeley, California, 94705, United States

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Los Angeles, California, 90033, United States

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Oceanside, California, 92056, United States

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Novartis Investigative Site

Sacramento, California, 95817, United States

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Aurora, Colorado, 80045, United States

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Basalt, Colorado, 81621, United States

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Boulder, Colorado, 80301, United States

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Colorado Springs, Colorado, 80907, United States

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Englewood, Colorado, 80113, United States

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Fairfield, Connecticut, 06824, United States

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Delray Beach, Florida, 33445, United States

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Novartis Investigative Site

Hollywood, Florida, 33024, United States

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Jacksonville, Florida, 32209, United States

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Maitland, Florida, 32751, United States

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Ormond Beach, Florida, 32174, United States

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Port Charlotte, Florida, 33952, United States

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Tampa, Florida, 33609, United States

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Tampa, Florida, 33612, United States

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Vero Beach, Florida, 32960, United States

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Chicago, Illinois, 60612, United States

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Evanston, Illinois, 60201, United States

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Flossmoor, Illinois, 60422, United States

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Lenexa, Kansas, 66212, United States

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Baltimore, Maryland, 21287, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202 2689, United States

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Plymouth, Minnesota, 55446, United States

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St Louis, Missouri, 63131, United States

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Las Vegas, Nevada, 89106, United States

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Lebanon, New Hampshire, 03756, United States

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Freehold, New Jersey, 07728, United States

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Albuquerque, New Mexico, 87131-0001, United States

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New York, New York, 10017, United States

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New York, New York, 10029, United States

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Patchogue, New York, 11772, United States

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Stony Brook, New York, 11794, United States

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Charlotte, North Carolina, 28207, United States

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Akron, Ohio, 44320, United States

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Dayton, Ohio, 45408, United States

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Portland, Oregon, 97225, United States

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Springfield, Oregon, 97477, United States

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Philadelphia, Pennsylvania, 19104, United States

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Providence, Rhode Island, 02905, United States

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Dallas, Texas, 75216, United States

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Lubbock, Texas, 79410, United States

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San Antonio, Texas, 78258, United States

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Burlington, Vermont, 05401, United States

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Seattle, Washington, 98101, United States

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Seattle, Washington, 98122, United States

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Milwaukee, Wisconsin, 53215, United States

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CABA, Buenos Aires, 1425, Argentina

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CABA, Buenos Aires, C1181ACH, Argentina

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CABA, Buenos Aires, C1428AQK, Argentina

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Capital Federal, Buenos Aires, 1424, Argentina

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Buenos Aires, C1424BYD, Argentina

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Córdoba, X5000FAL, Argentina

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Camperdown, New South Wales, 2050, Australia

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Kogarah, New South Wales, 2217, Australia

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Liverpool, New South Wales, 2170, Australia

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Heidelberg, Victoria, 3084, Australia

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Parkville, Victoria, 3050, Australia

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Klagenfurt, 9020, Austria

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Vienna, 1010, Austria

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Vienna, 1090, Austria

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Edegem, Antwerpen, 2650, Belgium

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Fraiture En Condroz, Belgium, 4557, Belgium

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Bruges, 8000, Belgium

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Brussels, 1070, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Overpelt, 3900, Belgium

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Sijsele, 8340, Belgium

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Sofia, 1113, Bulgaria

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Sofia, 1413, Bulgaria

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Sofia, 1431, Bulgaria

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Varna, 9010, Bulgaria

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Calgary, Alberta, T2N 2T9, Canada

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Edmonton, Alberta, T6G 2G3, Canada

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Burnaby, British Columbia, V5G 2X6, Canada

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Halifax, Nova Scotia, B3H 4K4, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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Montreal, Quebec, H2X 0A9, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Changchun, Jilin, 130021, China

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Taiyuan, Shanxi, 030001, China

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Xi’an, Shanxi, 710038, China

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Chengdu, Sichuan, 610041, China

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Beijing, 100028, China

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Beijing, 100034, China

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Beijing, 100730, China

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Shanghai, 200040, China

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Brno, Czech Rep., 625 00, Czechia

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Teplice, Czech Republic, 415 01, Czechia

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Jihlava, 586 01, Czechia

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Prague, 12808, Czechia

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Prague, 150 00, Czechia

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Tallinn, 10138, Estonia

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Tallinn, 10617, Estonia

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Bordeaux, 33076, France

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Caen, 14033, France

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Lille, 59037, France

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Marseille, 13885, France

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Montpellier, 34295, France

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Nancy, 54035, France

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Nîmes, 30029, France

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Paris, 75651, France

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Rennes, 35043, France

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Saint-Herblain, 44800, France

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Strasbourg, 67091, France

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Regensburg, Bavaria, 93053, Germany

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Aschaffenburg, 63739, Germany

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Bad Mergentheim, 97980, Germany

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Bayreuth, 95445, Germany

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Berg, 82335, Germany

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Berlin, 10713, Germany

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Berlin, 13347, Germany

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Bielefeld, 33647, Germany

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Bochum, 44791, Germany

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Bonn, 53111, Germany

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Böblingen, 71032, Germany

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Dresden, 01307, Germany

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Erbach im Odenwald, 64711, Germany

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Erlangen, 91054, Germany

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Frankfurt, 60313, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 20249, Germany

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Hamburg, 22083, Germany

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Hanover, 30171, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Homburg, 66421, Germany

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Itzehoe, 25524, Germany

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Jena, 07740, Germany

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Kassel, 34121, Germany

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Leipzig, 04103, Germany

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Leipzig, 04107, Germany

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München, 80377, Germany

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Münster, 48149, Germany

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Neuburg an der Donau, 86633, Germany

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Oldenburg, 26122, Germany

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Potsdam, 14471, Germany

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Prien am Chiemsee, 83209, Germany

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Rostock, 18057, Germany

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Schwendi, 88477, Germany

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Siegen, 57076, Germany

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Stade, 21682, Germany

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Stadtroda, 07646, Germany

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Teupitz, 15755, Germany

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Tübingen, 72076, Germany

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Ulm, 89073, Germany

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Ulm, 89081, Germany

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Unterhaching, 82008, Germany

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Wiesbaden, 65191, Germany

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Würzburg, 97080, Germany

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Athens, 106 76, Greece

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Heraklion Crete, 711 10, Greece

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Thessaloniki, GR 54636, Greece

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Budapest, HUN, 1135, Hungary

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Esztergom, HUN, 2500, Hungary

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Balassagyarmat, 2660, Hungary

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Budapest, 1085, Hungary

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Budapest, 1106, Hungary

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Budapest, 1145, Hungary

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Budapest, 1204, Hungary

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Eger, H-3300, Hungary

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Miskolc, 3526, Hungary

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Nyíregyháza, 4400, Hungary

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Veszprém, H 8200, Hungary

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Dublin, D04 T6F, Ireland

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Dublin, D09, Ireland

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Jerusalem, 9112001, Israel

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Ramat Gan, 52621, Israel

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Genova, GE, 16132, Italy

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Milan, MI, 20122, Italy

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Milan, MI, 20132, Italy

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Cefalù, PA, 90015, Italy

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Roma, RM, 00133, Italy

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Roma, RM, 00152, Italy

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Roma, RM, 00161, Italy

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Roma, RM, 00168, Italy

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Roma, RM, 00179, Italy

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Napoli, 80131, Italy

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Tōon, Ehime, 791-0295, Japan

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Asahikawa, Hokkaido, 070-8644, Japan

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Morioka, Iwate, 020-8505, Japan

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Kyoto, Kyoto, 616-8147, Japan

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Suita, Osaka, 565 0871, Japan

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Kawagoe, Saitama, 350 8550, Japan

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Tokorozawa, Saitama, 359 8513, Japan

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Kodaira, Tokyo, 187-8551, Japan

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Ōta-ku, Tokyo, 145-0065, Japan

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Shinjuku Ku, Tokyo, 162 8666, Japan

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Shinjuku-ku, Tokyo, 160 8582, Japan

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Aomori, 030 8553, Japan

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Chiba, 2608677, Japan

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Osaka, 556-0016, Japan

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Riga, LV, LV-1005, Latvia

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Riga, LV 1002, Latvia

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Riga, LV-1038, Latvia

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Kaunas, LTU, LT 50161, Lithuania

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Klaipėda, LT-92288, Lithuania

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Vilnius, LT-08661, Lithuania

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Amsterdam, 1105 AZ, Netherlands

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Breda, 4818 CK, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Hoorn, 1624 NP, Netherlands

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Sittard-Geleen, 6162 BG, Netherlands

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Tilburg, 5022 GC, Netherlands

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Gmina Końskie, 26 200, Poland

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Grudziądz, 86 300, Poland

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Katowice, 40 571, Poland

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Kielce, 25 726, Poland

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Krakow, 31-637, Poland

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Lodz, 90 324, Poland

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Poznan, 60-355, Poland

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Warsaw, 02-957, Poland

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Amadora, 2720-276, Portugal

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Braga, 4710243, Portugal

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Coimbra, 3000 075, Portugal

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Lisbon, 1649 035, Portugal

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Porto, 4099-001, Portugal

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Bucharest, 020125, Romania

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Bucharest, 050098, Romania

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Constanța, 900591, Romania

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Suceava, 727525, Romania

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Târgu Mureş, 540136, Romania

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Timișoara, 300736, Romania

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Barnaul, 656024, Russia

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Kazan', 420043, Russia

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Moscow, 119049, Russia

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Moscow, 127018, Russia

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Novosibirsk, 630007, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 197110, Russia

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Saint Petersburg, 197376, Russia

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Ufa, 450000, Russia

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Banská Bystrica, 97517, Slovakia

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Bratislava, 813 69, Slovakia

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Bratislava, 826 06, Slovakia

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Martin, 036 59, Slovakia

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Nitra, 94911, Slovakia

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Prešov, 081 81, Slovakia

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Trenčín, 91171, Slovakia

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Trnava, 917 75, Slovakia

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Málaga, Andalusia, 29010, Spain

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Seville, Andalusia, 41009, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Bilbao, Basque Country, 48013, Spain

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Donostia / San Sebastian, Basque Country, 20080, Spain

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Badalona, Catalonia, 08916, Spain

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Barcelona, Catalonia, 08003, Spain

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Barcelona, Catalonia, 08035, Spain

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El Palmar, Murcia, 30120, Spain

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Valencia, Valencia, 46010, Spain

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Barcelona, 08041, Spain

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Madrid, 28040, Spain

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Madrid, 28222, Spain

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Valencia, 46026, Spain

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Gothenburg, 413 45, Sweden

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Stockholm, 102 35, Sweden

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Stockholm, 10235, Sweden

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Aarau, CH, 5001, Switzerland

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Basel, 4031, Switzerland

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Lausanne, 1011, Switzerland

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Lucerne, 6000, Switzerland

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Lugano, 6900, Switzerland

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Sankt Gallen, 9007, Switzerland

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Zurich, 8091, Switzerland

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Istanbul, TUR, 34098, Turkey (Türkiye)

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Altunizade, 34662, Turkey (Türkiye)

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Haseki Istanbul, 34096, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Mecidiyekoy Istanbul, 34394, Turkey (Türkiye)

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Samsun, 55139, Turkey (Türkiye)

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Trabzon, 61080, Turkey (Türkiye)

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Salford, Manchester, M6 8HD, United Kingdom

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Headington, Oxfordshire, OX3 9DU, United Kingdom

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Sheffield, South Yorkshire, S10 2JF, United Kingdom

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Bristol, BS10 5NB, United Kingdom

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Glasgow, G51 4TF, United Kingdom

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Leeds, LS1 3EX, United Kingdom

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Leicester, LE5 4PW, United Kingdom

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London, EC1A 7BE, United Kingdom

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London, W8 6RF, United Kingdom

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Related Publications (7)

• 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.

  PMID: 35639197 DERIVED

• 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.

  PMID: 35380078 DERIVED

• 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.

  PMID: 35379762 DERIVED

• 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.

  PMID: 35261318 DERIVED

• 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.

  PMID: 33791945 DERIVED

• 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.

  PMID: 33328324 DERIVED

• 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.

  PMID: 29576505 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

siponimod

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 15, 2012
• Study Start: December 20, 2012
• Primary Completion: April 29, 2016
• Study Completion: March 31, 2023
• Last Updated: June 5, 2024
• Results First Posted: October 31, 2018

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

TU (7); JP (14); NL (6); SE (3); AR (6); AU (3); CH (7); IL (2); BE (8); CA (10); ES (14); GB (10); IE (2); FR (11); GR (3); LA (3); PT (5); RO (6); SL (8); RU (9); US (52); IT (10); LI (3); CN (8); BU (4); HU (11); PL (8); DE (45); CZ (5)