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Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01647516
First Posted: July 23, 2012
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  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: Quadruple (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 19, 2012
First Posted: July 23, 2012
Last Update Posted: June 20, 2017
Last Verified: June 2017

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