Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

• Status: Terminated
• Trial end date: 2020-03-26
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Dimethyl Fumarate; Ponesimod

Criteria

Inclusion Criteria:

• Signed informed consent prior to initiation of any study-mandated procedure.

• Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception

• Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).

• Ongoing treatment with DMF for at least 6 months prior to screening

• Active disease after at least 3 months of DMF treatment

• Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

Exclusion Criteria:

• Lactating or pregnant women and women intending to become pregnant during the study.

• Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).

• Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.