Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

This study is currently recruiting participants.
Verified April 2014 by Receptos, Inc.
Sponsor:
Information provided by (Responsible Party):
Receptos, Inc.
ClinicalTrials.gov Identifier:
NCT01647516
First received: July 19, 2012
Last updated: April 4, 2014
Last verified: April 2014
  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 Receptos, Inc.:

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

Estimated Enrollment: 180
Study Start Date: December 2012
Estimated Primary Completion Date: June 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 65 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647516

Contacts
Contact: Martine Oehling 910-558-6748 Martine.Oehling@ppdi.com

  Show 77 Study Locations
Sponsors and Collaborators
Receptos, Inc.
  More Information

No publications provided

Responsible Party: Receptos, Inc.
ClinicalTrials.gov Identifier: NCT01647516     History of Changes
Other Study ID Numbers: RPC01-202
Study First Received: July 19, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014