An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses 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 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011470-15-FI

Enrollment

353

Registered

2010-02-09

Start date

2010-03-30

Completion date

Unknown

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsing-remitting multiple sclerosis MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: ponesimod Product Code: ACT-128800 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: PONESIMOD Current Sponsor code: ACT-128800 Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who completed study treatment at their regular Week 24 (EOT) visit within the core study (AC-058B201). 2. Signed informed consent for participating in the extension study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 353 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients meeting any of the study-specific criteria for permanent discontinuation of study drug, or patients receiving any of the prohibited concomitant medication. 2. Any other 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: All objectives for this study are exploratory: - To investigate the long-term safety and tolerability of ponesimod. - To investigate the long-term efficacy of ponesimod. - To explore the dose response relationship of 10, 20 and 40 mg ponesimod on lymphocyte count, MRI endpoints, annualized relapse rate (ARR), and safety endpoints.;Secondary Objective: Not applicable;Primary end point(s): Only exploratory efficacy endpoints will be investigated. The following exploratory endpoints will be analyzed: 1. Annualized confirmed relapse rate. 2. Time to first confirmed relapse 3. Time to 24-week confirmed disability progression up to end of the study. Additional endpoints/parameters based on MRI scans, relapses as well as endpoints related to safety and tolerability will be investigated.;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: All objectives for this study are exploratory: - To investigate the long-term safety and tolerability of ponesimod. - To investigate the long-term efficacy of ponesimod. - To explore the dose response relationship of 10, 20 and 40 mg ponesimod on lymphocyte count, MRI endpoints, annualized relapse rate (ARR), and safety endpoints.;Secondary Objective: Not applicable;Primary end point(s): Only exploratory efficacy endpoints will be investigated. The following exploratory endpoints will be analyzed: 1. Annualized confirmed relapse rate. 2. Time to first confirmed relapse 3. Time to 24-week confirmed disability progression up to end of the study. Additional endpoints/parameters based on MRI scans, relapses as well as endpoints related to safety and tolerability will be investigated.;Timepoint(s) of evaluation of this end point: Not applicable

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Austria, Bulgaria, Canada, Czechia, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Registry group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com+3171 5242166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026