Back to resultsClinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ponesimod 10 mg
Ponesimod 20 mg
Ponesimod 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201.
- Signed informed consent for participating in the extension study.
Exclusion Criteria:
1. Any clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ponesimod 10 mg
Ponesimod 20 mg
Ponesimod 40 mg
Arm Description
Ponesimod 10 mg oral use
Ponesimod 20 mg oral use
Ponesimod 40 mg oral use
Outcomes
Primary Outcome Measures
Annualized confirmed relapse rate
IMPORTANT NOTE: Only exploratory analyses will be performed.
Time to first confirmed relapse
IMPORTANT NOTE: Only exploratory analyses will be performed.
Time to 24 Weeks Confirmed Disability Progression up to end of the study
IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the EDSS score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 24 weeks later (or if missing, at the next available scheduled EDSS assessment). The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01093326
Brief Title
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
Official Title
Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2010 (Actual)
Primary Completion Date
September 6, 2023 (Actual)
Study Completion Date
September 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ponesimod 10 mg
Arm Type
Experimental
Arm Description
Ponesimod 10 mg oral use
Arm Title
Ponesimod 20 mg
Arm Type
Experimental
Arm Description
Ponesimod 20 mg oral use
Arm Title
Ponesimod 40 mg
Arm Type
Experimental
Arm Description
Ponesimod 40 mg oral use
Intervention Type
Drug
Intervention Name(s)
Ponesimod 10 mg
Intervention Description
Ponesimod 10 mg oral use
Intervention Type
Drug
Intervention Name(s)
Ponesimod 20 mg
Intervention Description
Ponesimod 20 mg oral use
Intervention Type
Drug
Intervention Name(s)
Ponesimod 40 mg
Intervention Description
Ponesimod 40 mg oral use
Primary Outcome Measure Information:
Title
Annualized confirmed relapse rate
Description
IMPORTANT NOTE: Only exploratory analyses will be performed.
Time Frame
Up to 660 weeks (core plus extension)
Title
Time to first confirmed relapse
Description
IMPORTANT NOTE: Only exploratory analyses will be performed.
Time Frame
Up to 660 weeks (core plus extension)
Title
Time to 24 Weeks Confirmed Disability Progression up to end of the study
Description
IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the EDSS score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 24 weeks later (or if missing, at the next available scheduled EDSS assessment). The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression.
Time Frame
Up to 660 weeks (core plus extension)
Other Pre-specified Outcome Measures:
Title
(Serious) Adverse Events
Time Frame
Up to 660 weeks (core plus extension)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201.
Signed informed consent for participating in the extension study.
Exclusion Criteria:
1. Any clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study.
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Scottsdale
State/Province
Arizona
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Venice
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Lenexa
State/Province
Kansas
Country
United States
City
Latham
State/Province
New York
Country
United States
City
Schenectady
State/Province
New York
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Kirkland
State/Province
Washington
Country
United States
City
Vienna
Country
Austria
City
Sofia
Country
Bulgaria
City
Ottawa
State/Province
Ontario
Country
Canada
City
Brno
Country
Czechia
City
Jihlava
Country
Czechia
City
Olomouc
Country
Czechia
City
Ostrava-Poruba
Country
Czechia
City
Praha 2
Country
Czechia
City
Teplice
Country
Czechia
City
Helsinki
Country
Finland
City
Hyvinkää
Country
Finland
City
Tampere
Country
Finland
City
Turku
Country
Finland
City
Montpellier Cedex 5
Country
France
City
Berlin
Country
Germany
City
Essen
Country
Germany
City
Ulm
Country
Germany
City
Budapest
Country
Hungary
City
Esztergom
Country
Hungary
City
Győr
Country
Hungary
City
Miskolc
Country
Hungary
City
Tel-Hashomer
Country
Israel
City
Zerifin
Country
Israel
City
Breda
Country
Netherlands
City
Katowice
Country
Poland
City
Poznan
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Cluj-Napoca
Country
Romania
City
Timisoara
Country
Romania
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhniy Novgorod
Country
Russian Federation
City
Pyatigorsk
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Samara
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
UFA
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Kragujevac
Country
Serbia
City
Nis
Country
Serbia
City
Majadahonda
Country
Spain
City
Malaga
Country
Spain
City
Sevilla
Country
Spain
City
Göteborg
Country
Sweden
City
Stockholm
Country
Sweden
City
Umeå
Country
Sweden
City
Lugano
Country
Switzerland
City
Chernihiv
Country
Ukraine
City
Dnipropetrovsk
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Odesa
Country
Ukraine
City
Bristol
Country
United Kingdom
City
London
Country
United Kingdom
City
Plymouth
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
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