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:Recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 55
Updated:3/22/2019
Start Date:March 30, 2017
End Date:March 31, 2020
Contact:CTD Clinical Trial Disclosure Desk
Email:clinical-trials-disclosure@its.jnj.com
Phone:+41 (0)61 565 65 65

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Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority 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®)

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.
We found this trial at
30
sites
101 Forrest Crossing Boulevard
Franklin, Tennessee 37064
Phone: 615-791-5470
1761
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Franklin, TN
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3924 9th Avenue West
Bradenton, Florida 34205
Phone: 941-708-0005
2139
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Bradenton, FL
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
214
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Fresno, CA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Phone: 212-662-3647
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
2373
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Philadelphia, PA
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Albuquerque, New Mexico 87131
Phone: 505-272-0760
648
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Albuquerque, NM
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Phone: 303-724-2187
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
825
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Aurora, CO
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1720 2nd Avenue South
Birmingham, Alabama 35294
Phone: 205-934-2402
1785
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Birmingham, AL
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851 Broken Sound Parkway Northwest
Boca Raton, Florida 33487
Phone: 561-939-0300
2310
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Boca Raton, FL
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Cincinnati, Ohio 45242
Phone: 513-241-2370
1880
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Cincinnati, OH
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Columbus, Ohio 43214
Phone: 614-566-1250
1960
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Columbus, OH
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Danbury, Connecticut 06810
Phone: 203-748-2551
2458
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Danbury, CT
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Denver, Colorado 80209
Phone: 720-583-1754
818
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Denver, CO
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2799 West Grand Boulevard
Detroit, Michigan 48202
Phone: 313-916-7202
1965
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Detroit, MI
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Fort Wayne, Indiana 46825
Phone: 260-460-3100
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Fort Wayne, IN
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Heidelberg,
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-6980
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
1332
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Kansas City, KS
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301 North Maitland Avenue
Maitland, Florida 32751
Phone: 407-647-5996
2182
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Maitland, FL
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240 East 38th Street
New York, New York 10016
Phone: 646-501-7500
2434
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New York, NY
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5 East 98th Street
New York, New York 10029
Phone: 212-241-6854
2435
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New York, NY
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535 Northwest 9th Street
Oklahoma City, Oklahoma 73102
Phone: 405-534-5349
1164
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Oklahoma City, OK
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8 Mirror Lake Drive
Ormond Beach, Florida 32174
Phone: 386-676-6340
2183
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Ormond Beach, FL
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Overland Park, Kansas 66213
Phone: 913-827-4202
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Overland Park, KS
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Pasadena, California 91105
Phone: 626-250-2070
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Pasadena, CA
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900 Walnut Street
Philadelphia, Pennsylvania 19107
Phone: 215-955-6871
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Philadelphia, PA
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Saint Petersburg, Florida 33713
Phone: 727-202-2623
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Saint Petersburg, FL
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San Antonio, Texas 78258
Phone: 210-490-0016
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San Antonio, TX
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Santa Clarita, California 91350
Phone: 415-408-2360
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Santa Clarita, CA
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Tallahassee, Florida 32308
Phone: 850-558-1238
1980
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Tallahassee, FL
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Torrance, California 90502
Phone: 310-222-3897
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Torrance, CA
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Vero Beach, Florida 32960
Phone: 772-299-4304
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Vero Beach, FL
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