Skip to navigation Skip to content



MS Trial Alert: Investigators Recruiting Worldwide for Phase 3 Trial of Oral Ponesimod Added to Tecfidera®

October 30, 2017

SUMMARY: Investigators are recruiting 600 people with relapsing MS for a clinical trial examining the effectiveness of adding ponesimod, an oral compound that affects immune function, in people who are still experiencing relapses while taking Tecfidera® (dimethyl fumarate, Biogen, Inc.). The study sponsor is Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson.
Rationale: Multiple sclerosis involves an immune system attack on the brain and spinal cord. Ponesimod is a compound that binds to a docking site (sphingosine-1-phosphate receptor 1, or S1P1 receptor) on immune cells, including T cells and B cells (lymphocytes) that have been implicated in causing nervous system damage in MS. The once-a-day pill induces immune cells to remain in lymph nodes, inhibiting their migration into the brain and spinal cord. A similar therapy, Gilenya® (fingolimod, Novartis International AG) is approved by the U.S. FDA to treat relapsing MS. This trial asks the question of whether ponesimod, added to Tecfidera therapy, can reduce the incidence of MS relapses. In an earlier phase II study in people with MS, all three tested doses of ponesimod significantly reduced disease activity seen on MRI scans (Journal of Neurology, Neurosurgery and Psychiatry 2014 Nov; 85(11): 1198–1208). A phase 3 study of ponesimod versus teriflunomide is ongoing, but has completed its recruitment.
Eligibility and Details: Participants may include adult males and females aged 18 to 55 with a diagnosis of relapsing MS (including people with relapsing-remitting MS, and those with secondary-progressive MS experiencing relapses). Participants are required to have been taking Tecfidera for 6 months before enrolling in the study. Participants must also have experienced a relapse or have current disease activity on an MRI scan of the brain or spinal cord within 12 months prior to screening and after at least 3 months of Tecfidera treatment. Additional criteria – including previous treatment or medical conditions that might exclude individuals from participating – can be obtained by contacting the study investigators listed below.

Participants will be randomly assigned to receive oral ponesimod once daily or inactive placebo once daily, in addition to ongoing Tecfidera treatment, for a minimum of 60 weeks (for the last subject enrolled) up to a maximum of 156 weeks. The primary outcome being measured is the rate of relapses. Other outcomes being measured include disability progression, effect on brain tissue volume, time to first relapse, disease activity observed on MRI scans, fatigue, and adverse events.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you:
Dr. David Honeycutt  
Neurology Associates - MS Center of Greater Orlando
Maitland, FL
407-647-5966 x 204 ,
Dr. Aaron Boster        
OhioHealth Research Institute  
Columbus, OH
Dr. Samuel Hunter      
Advanced Neurosciences Institute
Franklin, TN         
Dr. Bennett Machanic 
Mountain View Clinical Research, Inc. 
Denver, CO
Dr. Vernon Rowe       
MidAmerica Neuroscience Research Foundation/Rowe Neurology Institute    
Lenexa, KS
Dr. James Scott 
Neurology Associates of Ormond Beach - CNS Trials       
Ormond Beach, FL
Dr. Ann Bass    
Neurology Center of San Antonio       
San Antonio, TX
Dr. Fred Lublin 
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for Multiple Sclerosis
New York, NY
Dr. Stephen Newman 
Island Neurological Associates, A Division of Prohealth Care Associates, LLP 
Plainview, NY
Dr. Thomas Leist        
Thomas Jefferson University Hospital - The Comprehensive MS Center
Philadelphia, PA
Dr. Sharon Lynch       
University of Kansas Medical Center   
Kansas City, KS
Dr. Ricardo Ayala       
Tallahassee Neurological Clinic  
Tallahassee, FL
Dr. Surisham Dhillon  
Care Access Research      
Santa Clarita, CA
Dr. Timothy Vollmer  
University of Colorado Hospital
Aurora, CO
Dr. Khurram Bashir    
University of Alabama, Dept. of Neurology   
Birmingham, AL
Dr. Ilya Kister   
NYU Langone Medical Center - MS Comprehensive Care Center
New York, NY
Dr. Bijal Mehta 
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center   
Torrance, CA
Dr. Colin Zadikoff
Riverhills Healthcare
Cincinnati, OH
Dr. Farhan Ahmed Tariq
Hightower Clinical
Oklahoma City, OK
Dr. Mirela Cerghet
Henry Ford Health System-Neurology
Detroit, MI
Dr. David Greco
Associated Neurologists
Danbury, CT
Dr. Perminder Bhatia
Neuro-Pain Medical Center
Fresno, CA
Dr. James Shafer
The MS Center of Vero Beach
Vero Beach, FL
Dr. Eric Williamson
Hospital of the University of Pennsylvania
Philadelphia, PA

Dr. Corey Ford
Univ of New Mexico - Health Sciences Center
Albuquerque, New Mexico
Dr. Surisham Dhillon
Care Access Research
Santa Clarita, CA
Dr. Khurram Bashir
UAB Dept. of Neurology
Birmingham, AL
Dr. Daniel Kantor
Florida Academic Research, LLC
Boca Raton, FL
Dr. Ahmed Farhan Tariq
Neurology and Neuromuscular Center
Oklahoma City, OK
Dr. David Greco
Associated Neurologists
Danbury, CT
Dr. Perminder Bhatia
Neuro-Pain Medical Center
Fresno, CA
Dr. Orlando Maldonado-Robles
Bradenton Research Center
Bradenton, FL

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill. Read more here.
Tecfidera® is a registered trademark of Biogen, Inc.
Gilenya® is a registered trademark of Novartis International AG

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


© 2020 The National Multiple Sclerosis Society is a tax exempt 501(c)3 nonprofit organization and our Identification Number (EIN) is 13-5661935.