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®)

ID#: NCT02907177

Age: 18 - 55 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: March 30, 2017

End Date: March 31, 2020

Contact Information:
Study Contact
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®).

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.