Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
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The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
Condition or 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.
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
Actual Study Start Date :
October 9, 2015
Estimated Primary Completion Date :
October 12, 2019
Estimated Study Completion Date :
October 12, 2019
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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