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 |
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).
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.
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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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 Carolina’s vibrant people and programs attest to the...
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112 Gainsborough Square
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
757-547-0798
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
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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
Philadelphia, Pennsylvania 19104
(215) 662-4000
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
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University of Utah Research is a major component in the life of the U benefiting...
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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
Ann Arbor, Michigan 48109
(734) 936-4000
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1025 Morehead Medical Drive
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chicago, Illinois 60611
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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University of Louisville The University of Louisville is a state supported research university located in...
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15451 San Fernando Mission Boulevard
Mission Hills, California 91345
Mission Hills, California 91345
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New York University School of Medicine NYU School of Medicine has a proud history that...
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University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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11457 Olde Cabin Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
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1710 Scott Street
San Francisco, California 94115
San Francisco, California 94115
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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