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

Use our guide to learn which trials are right for you!

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
Florida Medical Clinic
Zephyrhills, Florida 33542
?
mi
from
Zephyrhills, FL
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
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...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Gastroenterology Associates of Tidewater
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Brooke Army Medical Center
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!...
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
Indiana University Hospital
550 University Boulevard
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
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...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
?
mi
from
Lexington, KY
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Oregon Health and Science University
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...
?
mi
from
Portland, OR
Click here to add this to my saved trials
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...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Gastroenterology, Ltd.
1101 First Colonial Road
Virginia Beach, Virginia 23454
757-481-4817
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
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...
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
University of Maryland Medical Group
22 South Greene Street
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Johns Hopkins Clinical Research Network
1800 Orleans Street
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Woodholme Gastroenterology
Baltimore, Maryland 21208
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Gastroenterology Associates
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
?
mi
from
Belton, MO
Click here to add this to my saved trials
Boston Med Ctr
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Clinical Research Professionals, LLC - De Paul Medical Dr
Bridgeton, Missouri 63044
?
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Commonwealth Clinical Studies
Brockton, Massachusetts 02302
?
mi
from
Brockton, MA
Click here to add this to my saved trials
NY Scientific
2001 Oriental Boulevard
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Hospital Italiano
4190 Juan D. Peron
Buenos Aires, C1181
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Carolinas HealthCare System Digestive Health
1025 Morehead Medical Drive
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
UC Health Clinical Trials Office
Cincinnati, Ohio 45206
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clinical Research of West Florida - Clearwater
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Gastro Florida
Clearwater, Florida 33762
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Gastro Center of Maryland
Columbia, Maryland 21045
?
mi
from
Columbia, MD
Click here to add this to my saved trials
Consultants in Gastroenterology
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Ohio State University Clinical Trials Management Office
Columbus, Ohio
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Aurora Care Clinic
Costa Mesa, California 92627
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
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...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Advanced Pharma Research, Inc
Delray Beach, Florida 33445
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Dolphin Medical Research
Doral, Florida 33172
?
mi
from
Doral, FL
Click here to add this to my saved trials
Universal Axon Clinical Research, LLC
3650 Northwest 82nd Avenue
Doral, Florida 33166
?
mi
from
Doral, FL
Click here to add this to my saved trials
Ventavia Research Group, LLC
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Valley View Internal Medicine
Garden Grove, California 92843
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Gastro One
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Long Island Clinical Research Associates
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Gulf Coast Research Group LLC
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
The Methodist Hospital Research Institute
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston Endoscopy and Research Center
Houston, Texas 77079
?
mi
from
Houston, TX
Click here to add this to my saved trials
Davita Clinical Trials, LLC
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Grand Teton Research Group
Idaho Falls, Idaho 83404
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
East Carolina Gastroenterology
Jacksonville, North Carolina 28546
?
mi
from
Jacksonville, NC
Click here to add this to my saved trials
University of California, San Diego Medical Center
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Om Research
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Florida Center for Gastroenterology
Largo, Florida 33777
?
mi
from
Largo, FL
Click here to add this to my saved trials
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Gastrointestinal Biosciences
Los Angeles, California 90067
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Southern California Research Institute Medical Group Inc
Los Angeles, California 90045
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
University of Southern California- Keck School of Medicine
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Dean Foundation for Health, Research and Education Inc.
Madison, Wisconsin 53715
?
mi
from
Madison, WI
Click here to add this to my saved trials
Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Community Clinical Research Network
Marlborough, Massachusetts 01752
?
mi
from
Marlborough, MA
Click here to add this to my saved trials
Great Lakes Gastroenterology Research
Mentor, Ohio 44060
?
mi
from
Mentor, OH
Click here to add this to my saved trials
City Medical Group
1611 Northwest 12th Avenue
Miami, Florida 33130
?
mi
from
Miami, FL
Click here to add this to my saved trials
Advanced Clinical Research of Miami
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Regenerate Clinical Trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Advanced Clincial Research
Miami, Florida 33134
?
mi
from
Miami, FL
Click here to add this to my saved trials
Facey Medical Foundation (Parent)
15451 San Fernando Mission Boulevard
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
Advanced Research for Health Improvement, LLC
1168 Goodlette-Frank Road
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
Advanced Research Institute, Inc
New Port Richey, Florida
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
NSB Research
New Smyrna Beach, Florida 32174
?
mi
from
New Smyrna Beach, FL
Click here to add this to my saved trials
Icahn School of Medicine Mount Sinai Beth Isreal
New York, New York 10003
?
mi
from
New York, NY
Click here to add this to my saved trials
Weill-Cornell Medical College
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
Mount Sinai - PRIME
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Concord Medical Group PRIME
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
New York University School of Medicine
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
?
mi
from
New York, NY
Click here to add this to my saved trials
Arkansas Gastroenterology
North Little Rock, Arkansas
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Med-Care Research
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
Harmony Clinical Research, Inc.
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
DM Clinical Research
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
Alliance Clinical Research
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
University of Oklahoma
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...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Gastroenterology Associates of Orangeburg, PA
Orangeburg, South Carolina 29118
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Center For Digestive Health
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
IMIC
Palmetto Bay, Florida
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
Theia Clinical Research
4820 Park Boulevard North
Pinellas Park, Florida 33781
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
The Mayo Clinic
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina 27804
?
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
Washington University
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Clinical Research Professionals LLC - The Pines Court
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Clinical Research Professionals, LLC - Olde Cabin Rd
11457 Olde Cabin Road
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Gastroenterology Research Of San Antonio
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio Gastroenterology
520 East Euclid Avenue
San Antonio, Texas 78212
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Medical Associates Research Group
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
University of California at San Francisco (PARENT)
1710 Scott Street
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
University of Washington Medical Center
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials