Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/16/2019
Start Date:October 9, 2015
End Date:November 26, 2019

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A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy

The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.

This open-label trial is composed of two periods: Induction and Extension. All eligible
patients will be enrolled into the 12-Week Induction period and receive study medication.
Patients who complete the Induction period may then be eligible to enter the 100-Week
Extension period where they will continue to receive study medication.

Key Inclusion Criteria:

- Crohn's disease (CD) confirmed by endoscopy and histology

- Active disease as evaluated by Crohn's Disease Activity Index Score and Simple
Endoscopic Score for CD

- Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic
therapy

Key Exclusion Criteria:

- Diagnosis of ulcerative colitis or indeterminate colitis

- Known strictures/stenosis leading to symptoms of obstruction

- Current stoma or need for ileostomy or colostomy

- 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 known macular edema

- History of colonic dysplasia
We found this trial at
14
sites
Belton, Missouri 64012
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Belton, MO
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Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Cincinnati, Ohio 45206
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Cincinnati, OH
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Columbus, OH
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Germantown, Tennessee 38138
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Germantown, TN
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Largo, FL
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800 Commissioners Road East
London, Ontario N6A 5W9
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London,
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Oak Lawn, Illinois 60453
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Oak Lawn, IL
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Orangeburg, South Carolina 29118
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Orangeburg, SC
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Palmetto Bay, Florida
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Palmetto Bay, FL
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520 East Euclid Avenue
San Antonio, Texas 78212
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San Antonio, TX
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Suwanee, GA
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Tucson, Arizona 85712
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Tucson, AZ
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