Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Key facts

Study ID

NCT02435992

Run by

Celgene

People needed

1012

Starts

2015-06-17

Expected to finish

2020-06-17

Last updated by the study team

2021-09-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 to 75 years (at screening for Cohort 1 and 2)
• UC confirmed on endoscopy
• Moderately to severely active UC (May score 6-12)
• Currently receiving treatment with aminosalisylate, prednisone, or budesonide
• Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

You may not qualify if…

• Have severe extensive colitis as evidence by:
• Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
• Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
• Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, 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 or unknown macular edema
• Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Where it is running

• Adobe Clinical Research LLC — Tucson, Arizona, United States
• Arkansas Gastroenterology, P.A. — North Little Rock, Arkansas, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Aurora Care Clinic — Costa Mesa, California, United States
• Valley View Internal Medicine — Garden Grove, California, United States
• Davita Clinical Trials, LLC — Huntington Beach, California, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• OM Research — Lancaster, California, United States
• University of Southern California - Keck School of Medicine — Los Angeles, California, United States
• Southern California Research Institute Medical Group, Inc. — Los Angeles, California, United States
• Gastrointestinal Biosciences — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Facey Medical Foundation (Parent) — Mission Hills, California, United States
• Alliance Clinical Research, LLC — Oceanside, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• University of California at San Francisco (PARENT) — San Francisco, California, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Gastro Florida — Clearwater, Florida, United States
• Clinical Research of West Florida Inc - Clearwater — Clearwater, Florida, United States
• Advanced Pharma Research, Inc — Delray Beach, Florida, United States
• Universal Axon Clinical Research — Doral, Florida, United States
• Dolphin Medical Research — Doral, Florida, United States
• South Florida Clinical Trials — Hialeah, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• Arizona Digestive Health — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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