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
Danbury, Connecticut 06810
Phone: 203-748-2551
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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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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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5 East 98th Street
New York, New York 10029
Phone: 212-241-6854
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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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