Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
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
2 other identifiers
interventional
353
19 countries
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
Started May 2010
Longer than P75 for phase_2 multiple-sclerosis
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedStudy Start
First participant enrolled
May 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2023
CompletedResults Posted
Study results publicly available
October 1, 2024
CompletedMarch 30, 2025
March 1, 2025
13.3 years
March 24, 2010
September 3, 2024
March 28, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Annualized Relapse Rate (ARR) of Confirmed Relapses
ARR is defined as the number of confirmed relapses per year. A relapse is defined as the occurrence of an acute episode of one or more new symptoms, or worsening of existing symptoms of multiple sclerosis (MS), not associated with fever or infection, and lasting for at least 24 hours after a stable period of at least 30 days. A confirmed relapse is a relapse accompanied by an increase from the previous clinically stable assessment (that is, performed at least 30 days after the onset of any previous relapse) of at least 0.5 point in the Expanded Disability Status Scale (EDSS) score, or one point in the score for at least one of the Functional System (FS) scores, excluding the bowel and bladder, and mental FS. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10 (death due to MS).
From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years
Time to First Confirmed Relapse
Time to first confirmed relapse was reported. A relapse is defined as the occurrence of an acute episode of one or more new symptoms, or worsening of existing symptoms of multiple sclerosis (MS), not associated with fever or infection, and lasting for at least 24 hours after a stable period of at least 30 days. A confirmed relapse is a relapse accompanied by an increase from the previous clinically stable assessment (that is, performed at least 30 days after the onset of any previous relapse) of at least 0.5 point in the Expanded Disability Status Scale (EDSS) score, or one point in the score for at least one of the Functional System (FS) scores, excluding the bowel and bladder, and mental FS. EDSS is ordinal clinical scale ranges from 0 (normal neurological examination) to 10 (death due to MS).
From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years
Time to 24 Weeks Confirmed Disability Progression
Time to 24 weeks confirmed disability progression (accumulation) was reported. Disability progression is defined as an increase of at least 1 point in the EDSS score if baseline EDSS was between 1 and 5.0, an increase of at least 1.5 points if baseline EDSS was 0, or an increase of at least 0.5 points if the baseline EDSS was equal or greater than 5.5. A 24-week confirmed disability progression is defined as a 24-week sustained increase from baseline in the EDSS scores, that is, every EDSS score (scheduled or unscheduled, with or without relapse) within a 24-week duration after the first progression should meet the progression criteria as specified above. EDSS is ordinal clinical scale ranges from 0 (normal neurological examination) to 10 (death due to MS).
From ponesimod baseline up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years
Other Outcomes (1)
Number of Participants With at Least One Treatment-emergent Serious Adverse Events (SAEs)
From ponesimod start date up to the end of study treatment + 15 Days. The actual time of observation varied for each participant and could be up to 12.97 years + 15 days
Study Arms (3)
Ponesimod 10 mg
EXPERIMENTALPonesimod 10 mg oral use
Ponesimod 20 mg
EXPERIMENTALPonesimod 20 mg oral use
Ponesimod 40 mg
EXPERIMENTALPonesimod 40 mg oral use
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (71)
Unknown Facility
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Palo Alto, California, United States
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Sacramento, California, United States
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Venice, Florida, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Lenexa, Kansas, United States
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Latham, New York, United States
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Schenectady, New York, United States
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Stony Brook, New York, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Burlington, Vermont, United States
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Kirkland, Washington, United States
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Vienna, Austria
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Sofia, Bulgaria
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Ottawa, Ontario, Canada
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Brno, Czechia
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Jihlava, Czechia
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Olomouc, Czechia
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Ostrava-Poruba, Czechia
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Prague, Czechia
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Teplice, Czechia
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Helsinki, Finland
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Hyvinkää, Finland
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Tampere, Finland
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Turku, Finland
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Montpellier, France
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Berlin, Germany
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Essen, Germany
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Ulm, Germany
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Budapest, Hungary
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Esztergom, Hungary
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Győr, Hungary
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Miskolc, Hungary
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Tel Litwinsky, Israel
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Ẕerifin, Israel
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Breda, Netherlands
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Katowice, Poland
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Poznan, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Cluj-Napoca, Romania
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Timișoara, Romania
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Kazan', Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Pyatigorsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Ufa, Russia
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Belgrade, Serbia
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Kragujevac, Serbia
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Niš, Serbia
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Majadahonda, Spain
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Málaga, Spain
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Seville, Spain
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Gothenburg, Sweden
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Stockholm, Sweden
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Umeå, Sweden
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Lugano, Switzerland
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Chernihiv, Ukraine
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Dnipropetrovsk, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Bristol, United Kingdom
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London, United Kingdom
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Plymouth, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Leader Neuroscience
- Organization
- Actelion Pharmaceuticals Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 25, 2010
Study Start
May 12, 2010
Primary Completion
September 6, 2023
Study Completion
September 6, 2023
Last Updated
March 30, 2025
Results First Posted
October 1, 2024
Record last verified: 2025-03