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
sites
Click here to add this to my saved trials
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
112 Gainsborough Square
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
757-547-0798
Click here to add this to my saved trials
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
Click here to add this to my saved trials
Click here to add this to my saved trials
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
Click here to add this to my saved trials
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
Click here to add this to my saved trials
University of Utah Research is a major component in the life of the U benefiting...
Click here to add this to my saved trials
Click here to add this to my saved trials
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1025 Morehead Medical Drive
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Click here to add this to my saved trials
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
Click here to add this to my saved trials
Click here to add this to my saved trials
Chicago, Illinois 60611
Click here to add this to my saved trials
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Louisville The University of Louisville is a state supported research university located in...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
15451 San Fernando Mission Boulevard
Mission Hills, California 91345
Mission Hills, California 91345
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
New York University School of Medicine NYU School of Medicine has a proud history that...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
11457 Olde Cabin Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1710 Scott Street
San Francisco, California 94115
San Francisco, California 94115
Click here to add this to my saved trials
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials