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
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5 East 98th Street
New York, New York 10029
Phone: 212-241-6854
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3924 9th Avenue West
Bradenton, Florida 34205
Phone: 941-708-0005
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
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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...
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Albuquerque, New Mexico 87131
Phone: 505-272-0760
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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...
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1720 2nd Avenue South
Birmingham, Alabama 35294
Phone: 205-934-2402
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851 Broken Sound Parkway Northwest
Boca Raton, Florida 33487
Phone: 561-939-0300
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Cincinnati, Ohio 45242
Phone: 513-241-2370
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Columbus, Ohio 43214
Phone: 614-566-1250
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Danbury, Connecticut 06810
Phone: 203-748-2551
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Denver, Colorado 80209
Phone: 720-583-1754
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2799 West Grand Boulevard
Detroit, Michigan 48202
Phone: 313-916-7202
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Fort Wayne, Indiana 46825
Phone: 260-460-3100
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101 Forrest Crossing Boulevard
Franklin, Tennessee 37064
Phone: 615-791-5470
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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...
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301 North Maitland Avenue
Maitland, Florida 32751
Phone: 407-647-5996
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240 East 38th Street
New York, New York 10016
Phone: 646-501-7500
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535 Northwest 9th Street
Oklahoma City, Oklahoma 73102
Phone: 405-534-5349
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8 Mirror Lake Drive
Ormond Beach, Florida 32174
Phone: 386-676-6340
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Overland Park, Kansas 66213
Phone: 913-827-4202
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Pasadena, California 91105
Phone: 626-250-2070
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900 Walnut Street
Philadelphia, Pennsylvania 19107
Phone: 215-955-6871
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Saint Petersburg, Florida 33713
Phone: 727-202-2623
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San Antonio, Texas 78258
Phone: 210-490-0016
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Santa Clarita, California 91350
Phone: 415-408-2360
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Tallahassee, Florida 32308
Phone: 850-558-1238
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Torrance, California 90502
Phone: 310-222-3897
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Vero Beach, Florida 32960
Phone: 772-299-4304
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