Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT01647516
First received: July 19, 2012
Last updated: June 30, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

Condition Intervention Phase
Ulcerative Colitis
Drug: RPC1063
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Remission [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: December 2012
Estimated Study Completion Date: December 2019
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPC1063 Low Dose
oral, low dose, daily for 32 weeks
Drug: RPC1063
Experimental: RPC1063 High Dose
oral, high dose, daily for 32 weeks
Drug: RPC1063
Placebo Comparator: Placebo
oral, one capsule, daily for 32 weeks
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ulcerative colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

  • Current use of anti-TNF agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647516

  Show 59 Study Locations
Sponsors and Collaborators
Celgene
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01647516     History of Changes
Other Study ID Numbers: RPC01-202 
Study First Received: July 19, 2012
Last Updated: June 30, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ulcer
Colitis, Ulcerative
Colitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 22, 2016