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
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1168 Goodlette-Frank Road
Naples, Florida 34102
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Fort Sam Houston, Texas 78234
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701 Doctors Dr
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Lexington, Kentucky 40536
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503 494-8311
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201 Presidents Circle
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500 S Preston St
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1959 NE Pacific St
Seattle, Washington 98195
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