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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093326
• Other study ID #: AC-058B202
• Secondary ID: 2009-011470-15
• Status: Completed
• Phase: Phase 2
• Start date: May 12, 2010
• Est. completion date: September 6, 2023

Study information

• Verified date: October 2023
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Ponesimod 10 mg
Ponesimod 10 mg oral use
• Ponesimod 20 mg
Ponesimod 20 mg oral use
• Ponesimod 40 mg
Ponesimod 40 mg oral use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	(Serious) Adverse Events		Up to 660 weeks (core plus extension)
Primary	Annualized confirmed relapse rate	IMPORTANT NOTE: Only exploratory analyses will be performed.	Up to 660 weeks (core plus extension)
Primary	Time to first confirmed relapse	IMPORTANT NOTE: Only exploratory analyses will be performed.	Up to 660 weeks (core plus extension)
Primary	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.	Up to 660 weeks (core plus extension)