Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/30/2019
Start Date:June 17, 2015
End Date:July 29, 2020
Contact:Receptos True North Study
Email:truenorth@quintiles.com
Phone:1-844-266-9299

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

The purpose of this study is to determine whether RPC1063 is effective in the treatment of
Ulcerative Colitis (UC).

The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into
the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in
clinical response at the end of the Induction Period will proceed through to the Maintenance
Period. Participation in these periods will be 52 weeks. Patients may also qualify to
participate in an optional Open-Label Extension study.

Key Inclusion Criteria:

- Ulcerative Colitis (UC) confirmed on endoscopy

- Moderately to severely active UC (Mayo score 6-12)

- Currently receiving treatment with aminosalisylate, prednisone, or budesonide

Key Exclusion Criteria:

- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a
fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or
ischemic colitis

- Clinically relevant cardiovascular conditions or other relevant diseases that could
impact the implementation or interpretation of the trial, or put the patient at risk

- History of uveitis macular edema

- Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG)
measured during Screening
We found this trial at
111
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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550 University Boulevard
Indianapolis, Indiana 46202
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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740 South Limestone Street
Lexington, Kentucky 40536
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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1101 First Colonial Road
Virginia Beach, Virginia 23454
757-481-4817
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Asheville, North Carolina 28801
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Atlanta, Georgia 30342
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22 South Greene Street
Baltimore, Maryland 21201
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1800 Orleans Street
Baltimore, Maryland 21287
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Baltimore, Maryland 21208
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Baton Rouge, Louisiana 70809
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Belton, Missouri 64012
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Boston, Massachusetts 02118
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Brockton, Massachusetts 02302
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2001 Oriental Boulevard
Brooklyn, New York 11235
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4190 Juan D. Peron
Buenos Aires, C1181
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1025 Morehead Medical Drive
Charlotte, North Carolina 28204
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Charlottesville, Virginia 22903
(434) 924-0311
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Chevy Chase, Maryland 20815
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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Cincinnati, Ohio 45206
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Clearwater, Florida 33762
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Columbia, Maryland 21045
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Columbia, South Carolina 29203
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Costa Mesa, California 92627
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Delray Beach, Florida 33445
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Doral, Florida 33172
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3650 Northwest 82nd Avenue
Doral, Florida 33166
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Fort Worth, Texas 76104
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Garden Grove, California 92843
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Germantown, Tennessee 38138
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Great Neck, New York 11021
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Houston, Texas 77004
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Huntington Beach, California 92646
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Idaho Falls, Idaho 83404
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Jacksonville, North Carolina 28546
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Lancaster, California 93534
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Lebanon, New Hampshire 03756
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Los Angeles, California 90067
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Marietta, Georgia 30060
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Marlborough, Massachusetts 01752
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1611 Northwest 12th Avenue
Miami, Florida 33130
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Miami, Florida 33155
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Miami, Florida 33134
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15451 San Fernando Mission Boulevard
Mission Hills, California 91345
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1168 Goodlette-Frank Road
Naples, Florida 34102
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New Smyrna Beach, Florida 32174
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New York, New York 10016
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550 1st Ave
New York, New York 10016
(212) 263-7300
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North Little Rock, Arkansas
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North Miami Beach, Florida 33162
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Oak Lawn, Illinois 60453
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Oceanside, California 92056
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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Orangeburg, South Carolina 29118
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Orlando, Florida 32803
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4820 Park Boulevard North
Pinellas Park, Florida 33781
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Rochester, Minnesota 55905
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Rocky Mount, North Carolina 27804
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Saint Louis, Missouri 63110
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11457 Olde Cabin Road
Saint Louis, Missouri 63141
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San Antonio, Texas 78229
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520 East Euclid Avenue
San Antonio, Texas 78212
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San Diego, California 92123
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1710 Scott Street
San Francisco, California 94115
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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505 Nolen Drive
Southlake, Texas 76092
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