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Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

This study is currently recruiting participants.
Verified May 2017 by Celgene
Sponsor:
ClinicalTrials.gov Identifier:
NCT02531126
First Posted: August 24, 2015
Last Update Posted: June 2, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  Purpose
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients diagnosed with moderate to severe ulcerative colitis.

Condition Intervention Phase
Ulcerative Colitis Drug: RPC1063 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Safety as assessed by the evaluation of adverse events [ Time Frame: Up to 5 years ]
  • Efficacy as assessed by Mayo component sub-scores [ Time Frame: Up to 5 years ]

Estimated Enrollment: 1200
Actual Study Start Date: December 2, 2015
Estimated Study Completion Date: September 30, 2020
Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPC0163 (Ozanimod) Drug: RPC1063
Other Name: Ozanimod

Detailed Description:
The trial is an open label extension study. Eligible patients from the RPC01-3101 trial diagnosed with moderate to severe ulcerative colitis will be enrolled to receive study medication for up to 5 years or until marketed approval.
  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:

  • Previous participation on a trial of RPC1063 for ulcerative colitis (UC) and may benefit from continued treatment

Exclusion Criteria:

  • Require initiation of other therapies used in the treatment of UC
  • Pregnant, lactating, or have a positive serum pregnancy test
  • Have clinically relevant cardiovascular conditions or other relevant disease that would put the patient at risk or make interpretation of the trial difficult
  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): NCT02531126


Contacts
Contact: Receptos True North Study 1-844-266-9299 truenorth@quintiles.com

  Show 269 Study Locations
Sponsors and Collaborators
Celgene
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02531126     History of Changes
Other Study ID Numbers: RPC01-3102
First Submitted: August 20, 2015
First Posted: August 24, 2015
Last Update Posted: June 2, 2017
Last Verified: May 2017

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