Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

This study is currently recruiting participants.

Verified May 2013 by Receptos, Inc.

Sponsor:

Information provided by (Responsible Party):

Receptos, Inc.

ClinicalTrials.gov Identifier:

NCT01647516

First received: July 19, 2012

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

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:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

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

Locations

United States, California
	Recruiting
Anaheim, California, United States
	Recruiting
La Jolla, California, United States
United States, Georgia
	Recruiting
Atlanta, Georgia, United States
United States, Maryland
	Recruiting
Chevy Chase, Maryland, United States
United States, North Carolina
	Recruiting
Chapel Hill, North Carolina, United States
United States, Ohio
	Recruiting
Cincinnati, Ohio, United States
Belgium
	Recruiting
Leuven, Belgium
Canada, Ontario
London Health Science Center - Victoria Hospital	Recruiting
London, Ontario, Canada
London Health Science Center - University Hospital	Recruiting
London, Ontario, Canada
Hungary
	Recruiting
Budapest, Hungary
	Recruiting
Debrecen, Hungary
Korea, Republic of
	Recruiting
Wonju, Kangwon-do, Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University	Recruiting
Seoul, Korea, Republic of
Severance Hospital	Recruiting
Seoul, Korea, Republic of
Kyung Hee University Medical Center	Recruiting
Seoul, Korea, Republic of
New Zealand
	Recruiting
Hamilton, New Zealand
	Recruiting
Lower Hutt, New Zealand
Poland
	Recruiting
Bialystok, Poland
	Recruiting
Czestochowa, Poland
	Recruiting
Lodz, Poland
Slovakia
	Recruiting
Nitra, Slovakia
	Recruiting
Presov, Slovakia

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:	May 7, 2013
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 May 19, 2013

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