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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Trial Summary
Trial Overview
Inclusion Criteria

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
sites
Gastroenterology, Ltd.
1101 First Colonial Road
Virginia Beach, Virginia 23454
757-481-4817
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Montefiore Medical Center
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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University of North Carolina at Chapel Hill
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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Gastroenterology Associates of Tidewater
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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Brooke Army Medical Center
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
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Indiana University Hospital
550 University Boulevard
Indianapolis, Indiana 46202
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Kinston Medical Specialists
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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University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
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Vanderbilt University Medical Center
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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Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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University of Utah
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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Anaheim Clinical Trials, LLC
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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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina 28801
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Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
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University of Maryland Medical Group
22 South Greene Street
Baltimore, Maryland 21201
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Johns Hopkins Clinical Research Network
1800 Orleans Street
Baltimore, Maryland 21287
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Woodholme Gastroenterology
Baltimore, Maryland 21208
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Gastroenterology Associates
Baton Rouge, Louisiana 70809
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Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
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Boston Med Ctr
Boston, Massachusetts 02118
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Clinical Research Professionals, LLC - De Paul Medical Dr
Bridgeton, Missouri 63044
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
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NY Scientific
2001 Oriental Boulevard
Brooklyn, New York 11235
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Hospital Italiano
4190 Juan D. Peron
Buenos Aires, C1181
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Carolinas HealthCare System Digestive Health
1025 Morehead Medical Drive
Charlotte, North Carolina 28204
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University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
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Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
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Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
Chicago, Illinois 60611
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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UC Health Clinical Trials Office
Cincinnati, Ohio 45206
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Clinical Research of West Florida - Clearwater
Clearwater, Florida 33765
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Gastro Florida
Clearwater, Florida 33762
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Gastro Center of Maryland
Columbia, Maryland 21045
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Consultants in Gastroenterology
Columbia, South Carolina 29203
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Ohio State University Clinical Trials Management Office
Columbus, Ohio
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Aurora Care Clinic
Costa Mesa, California 92627
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Baylor Research Institute
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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Advanced Pharma Research, Inc
Delray Beach, Florida 33445
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Dolphin Medical Research
Doral, Florida 33172
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Universal Axon Clinical Research, LLC
3650 Northwest 82nd Avenue
Doral, Florida 33166
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Ventavia Research Group, LLC
Fort Worth, Texas 76104
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Valley View Internal Medicine
Garden Grove, California 92843
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Gastro One
Germantown, Tennessee 38138
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Long Island Clinical Research Associates
Great Neck, New York 11021
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
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Gulf Coast Research Group LLC
Houston, Texas 77004
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The Methodist Hospital Research Institute
Houston, Texas 77030
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Houston Endoscopy and Research Center
Houston, Texas 77079
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Davita Clinical Trials, LLC
Huntington Beach, California 92646
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Grand Teton Research Group
Idaho Falls, Idaho 83404
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East Carolina Gastroenterology
Jacksonville, North Carolina 28546
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University of California, San Diego Medical Center
La Jolla, California 92093
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Om Research
Lancaster, California 93534
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Florida Center for Gastroenterology
Largo, Florida 33777
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Largo, FL
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Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756
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Gastrointestinal Biosciences
Los Angeles, California 90067
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Southern California Research Institute Medical Group Inc
Los Angeles, California 90045
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University of Southern California- Keck School of Medicine
Los Angeles, California 90033
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Dean Foundation for Health, Research and Education Inc.
Madison, Wisconsin 53715
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
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Community Clinical Research Network
Marlborough, Massachusetts 01752
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Great Lakes Gastroenterology Research
Mentor, Ohio 44060
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Mentor, OH
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City Medical Group
1611 Northwest 12th Avenue
Miami, Florida 33130
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Advanced Clinical Research of Miami
Miami, Florida 33155
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Regenerate Clinical Trials
Miami, Florida 33155
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Advanced Clincial Research
Miami, Florida 33134
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Facey Medical Foundation (Parent)
15451 San Fernando Mission Boulevard
Mission Hills, California 91345
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Mission Hills, CA
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Advanced Research for Health Improvement, LLC
1168 Goodlette-Frank Road
Naples, Florida 34102
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Naples, FL
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Advanced Research Institute, Inc
New Port Richey, Florida
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NSB Research
New Smyrna Beach, Florida 32174
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Icahn School of Medicine Mount Sinai Beth Isreal
New York, New York 10003
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Weill-Cornell Medical College
New York, New York 10021
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Mount Sinai - PRIME
New York, New York 10029
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Concord Medical Group PRIME
New York, New York 10016
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New York University School of Medicine
550 1st Ave
New York, New York 10016
(212) 263-7300
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Arkansas Gastroenterology
North Little Rock, Arkansas
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Med-Care Research
North Miami Beach, Florida 33162
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Harmony Clinical Research, Inc.
North Miami Beach, Florida 33162
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DM Clinical Research
Oak Lawn, Illinois 60453
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Alliance Clinical Research
Oceanside, California 92056
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University of Oklahoma
1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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Gastroenterology Associates of Orangeburg, PA
Orangeburg, South Carolina 29118
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Center For Digestive Health
Orlando, Florida 32803
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IMIC
Palmetto Bay, Florida
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Theia Clinical Research
4820 Park Boulevard North
Pinellas Park, Florida 33781
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The Mayo Clinic
Rochester, Minnesota 55905
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PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina 27804
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Washington University
Saint Louis, Missouri 63110
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Clinical Research Professionals LLC - The Pines Court
Saint Louis, Missouri 63141
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Clinical Research Professionals, LLC - Olde Cabin Rd
11457 Olde Cabin Road
Saint Louis, Missouri 63141
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Gastroenterology Research Of San Antonio
San Antonio, Texas 78229
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San Antonio Gastroenterology
520 East Euclid Avenue
San Antonio, Texas 78212
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Medical Associates Research Group
San Diego, California 92123
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University of California at San Francisco (PARENT)
1710 Scott Street
San Francisco, California 94115
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University of Washington Medical Center
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101
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Texas Digestive Disease Consultants - Southlake
505 Nolen Drive
Southlake, Texas 76092
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