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Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Celgene
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02435992
First received: April 24, 2015
Last updated: May 4, 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 3

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 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 10 ]
    Induction Period

  • Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 52 ]
    Maintenance Period


Estimated Enrollment: 900
Actual Study Start Date: May 31, 2015
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPC1063 (Ozanimod)
1mg, daily oral administration during Induction and Maintenance periods.
Drug: RPC1063
Placebo Comparator: Placebo
Daily oral administration during Induction and Maintenance periods.
Drug: Placebo

Detailed Description:
The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in clinical response at the end of the Induction Period will proceed through to the Maintenance Period. Participation in these periods will be 52 weeks. Patients may also qualify to participate in an optional Open-Label Extension study.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Ulcerative Colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide

Key Exclusion Criteria:

  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
  • History of uveitis macular edema
  • Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during Screening
  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: NCT02435992

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

  Show 254 Study Locations
Sponsors and Collaborators
Celgene
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02435992     History of Changes
Other Study ID Numbers: RPC01-3101
Study First Received: April 24, 2015
Last Updated: May 4, 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 June 23, 2017