臨床研究等提出・公開システム

Date of registration	Feb. 19, 2014
Last modified on	Sept. 18, 2025
Trial ID	jRCT2080222397

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

Completion Date or Terminated date	Mar. 31, 2023
Actual Enrolled Number
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Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
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Plan to share IPD	Yes
Plan description	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name	Maruyama Hideki
	Contact Name for Scientific Queries	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Phone Number	+81-120-003-293
	E-mail Address	rinshoshiken.toroku@novartis.com

Contact for Public Queries	Name	Maruyama Hideki
	Contact Name for Public Queries	Novartis Pharma K. K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Phone Number	+81-120-003-293
	E-mail Address	rinshoshiken.toroku@novartis.com

Recruitment Status	completed

Date of First Enrolment		June. 04, 2014
Target Sample Size		1530
Study Type		Interventional
Study Design	Study Design	A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion 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 Other protocol defined inclusion/exclusion may apply
	Minimum Age	18age old over
	Maximum Age	60age old under
	Gender	Both
Health Condition or Problem Studied		Secondary Progressive Multiple Sclerosis
Intervention(s)		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 Investigational material : BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Matching Placebo administered orally.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		The delay in time to confirmed disability progression as measured by EDSS.
Secondary Outcome		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.

Primary Sponsor	Novartis Pharma K.K.
Secondary Sponsor

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Hospital Organization Hokkaido Medical Center
Address of IRB	7-1-1, Yamanote 5jo, Nishi-ku, Sapporo-city, Hokkaido 063-0005 Japan
Phone Number of IRB	+81-11-611-8111
E-mail Address of IRB	101-chiken1@mail.hosp.go.jp
Status of IRB Review	approved
Date of Approval by IRB	Feb. 28, 2014

Secondary ID No.	JapicCTI-142447
Name of Other Registries	Japic

Secondary ID No.	NCT01665144
Name of Other Registries	Clinical Traials.gov

Countries / Regions of Recruitment	United States/United Kingdom/France/Germany/Greece/Hungary/Ireland/Israel/Italy/Latvia/Lithuania/Argentina/Australia/Austria/Belgium/Bulgaria/Canada/China/Czech Republic/Egypt/Estonia

History of Changes

No	Publication date
10	Sept. 18, 2025	(this page)	Changes
9	Sept. 17, 2025	Detail	Changes
8	June. 25, 2023	Detail	Changes
7	Dec. 17, 2018	Detail	Changes
6	June. 03, 2016	Detail	Changes
5	June. 03, 2016	Detail	Changes
4	Aug. 22, 2014	Detail	Changes
3	Aug. 22, 2014	Detail	Changes
2	Feb. 19, 2014	Detail	Changes
1	Feb. 19, 2014	Detail

List of change history