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®)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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®).

Key facts

Study ID

NCT02907177

Run by

Actelion

People needed

136

Starts

2017-03-30

Expected to finish

2020-03-26

Last updated by the study team

2021-05-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Neuro-Pain Medical Center — Fresno, California, United States
• SC3 Research - Pasadena — Pasadena, California, United States
• Care Access Research - Santa Clarita — Santa Clarita, California, United States
• Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Mountain View Clinical Research, Inc — Denver, Colorado, United States
• Associated Neurologists — Danbury, Connecticut, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Neurology Associates - MS Center of Greater Orlando — Maitland, Florida, United States
• Neurology Assoc of Ormond Beach - CNS Trials — Ormond Beach, Florida, United States
• Suncoast Neuroscience Associates, Inc — St. Petersburg, Florida, United States
• The MS Center of Vero Beach — Vero Beach, Florida, United States
• Fort Wayne Neurological Center - North Office — Fort Wayne, Indiana, United States
• University of Kansas Med Center — Kansas City, Kansas, United States
• MidAmerica Neuroscience Research Foundation/Rowe Neurology — Lenexa, Kansas, United States
• Henry Ford Health System - Neurology — Detroit, Michigan, United States
• Univ of New Mexico - Health Sciences Center — Albuquerque, New Mexico, United States
• NYU Langone Medical Center - MS Comprehensive Care Center — New York, New York, United States
• Riverhills Healthcare, Inc. — Cincinnati, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• Neurology and Neuromuscular Center — Oklahoma City, Oklahoma, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital - Dpt Neurology MS Center — Philadelphia, Pennsylvania, United States
• Advanced Neuroscience Institute — Franklin, Tennessee, United States
• UAB Dpt of Neurology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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