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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: May 3, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Remission [ Time Frame: Week 8 ]

Enrollment: 197
Actual Study Start Date: December 12, 2012
Estimated Study Completion Date: December 31, 2019
Primary Completion Date: October 8, 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)
Sexes Eligible for Study:   All
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 56 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: May 3, 2017

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

ClinicalTrials.gov processed this record on May 25, 2017