Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis

March 28, 2025 updated by: Actelion

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
353

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
  • Bulgaria
      • Sofia, Bulgaria
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
  • Czechia
      • Brno, Czechia
      • Jihlava, Czechia
      • Olomouc, Czechia
      • Ostrava-Poruba, Czechia
      • Praha 2, Czechia
      • Teplice, Czechia
  • Finland
      • Helsinki, Finland
      • Hyvinkää, Finland
      • Tampere, Finland
      • Turku, Finland
  • France
      • Montpellier Cedex 5, France
  • Germany
      • Berlin, Germany
      • Essen, Germany
      • Ulm, Germany
  • Hungary
      • Budapest, Hungary
      • Esztergom, Hungary
      • Győr, Hungary
      • Miskolc, Hungary
  • Israel
      • Tel-Hashomer, Israel
      • Zerifin, Israel
  • Netherlands
      • Breda, Netherlands
  • Poland
      • Katowice, Poland
      • Poznan, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • Romania
      • Cluj-Napoca, Romania
      • Timisoara, Romania
  • Russian Federation
      • Kazan, Russian Federation
      • Moscow, Russian Federation
      • Nizhniy Novgorod, Russian Federation
      • Pyatigorsk, Russian Federation
      • Saint Petersburg, Russian Federation
      • Samara, Russian Federation
      • Saratov, Russian Federation
      • St. Petersburg, Russian Federation
      • UFA, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Kragujevac, Serbia
      • Nis, Serbia
  • Spain
      • Majadahonda, Spain
      • Malaga, Spain
      • Sevilla, Spain
  • Sweden
      • Göteborg, Sweden
      • Stockholm, Sweden
      • Umeå, Sweden
  • Switzerland
      • Lugano, Switzerland
  • Ukraine
      • Chernihiv, Ukraine
      • Dnipropetrovsk, Ukraine
      • Kyiv, Ukraine
      • Odesa, Ukraine
  • United Kingdom
      • Bristol, United Kingdom
      • London, United Kingdom
      • Plymouth, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
    • California
      • Palo Alto, California, United States
      • Sacramento, California, United States
    • Florida
      • Venice, Florida, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Lenexa, Kansas, United States
    • New York
      • Latham, New York, United States
      • Schenectady, New York, United States
      • Stony Brook, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
    • Vermont
      • Burlington, Vermont, United States
    • Washington
      • Kirkland, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201.
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ponesimod 10 mg
Ponesimod 10 mg oral use
Drug: Ponesimod 10 mg
Ponesimod 10 mg oral use
Experimental: Ponesimod 20 mg
Ponesimod 20 mg oral use
Drug: Ponesimod 20 mg
Ponesimod 20 mg oral use
Experimental: Ponesimod 40 mg
Ponesimod 40 mg oral use
Drug: Ponesimod 40 mg
Ponesimod 40 mg oral use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Annualized Relapse Rate (ARR) of Confirmed Relapses
Time Frame: 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
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 Frame: 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 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 Frame: 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
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: 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
Number of participants with at least one treatment-emergent SAEs were reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Treatment-emergent SAEs were those SAEs that occurred at or after the initial administration of ponesimod up to 15 days (inclusive) after last administration of ponesimod as study drug.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-058B202
  • 2009-011470-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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