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

Phase 2

Completed

• Conditions: ms; 10012303; relapsing remitting multiple sclerosis

• Registration Number: NL-OMON55638
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Only exploratory efficacy endpoints will be investigated.<br /><br>The following exploratory endpoints will be analyzed:<br /><br>- Annualized confirmed relapse rate.<br /><br>- Time to first confirmed relapse.<br /><br>- Time to 3-/6-months confirmed disability progression up to end of the study.<br /><br>Additional endpoints/parameters based on MRI scans, relapses as well as<br /><br>endpoints related to safety and tolerability will be investigated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>