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Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02531113
First received: August 20, 2015
Last updated: August 31, 2017
Last verified: August 2017
  Purpose
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.

Condition Intervention Phase
Crohn's Disease Drug: RPC1063 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Change in Simple Endoscopic Score for Crohn's Disease [ Time Frame: Week 12 ]
    Induction Period


Enrollment: 69
Actual Study Start Date: October 9, 2015
Estimated Study Completion Date: October 12, 2019
Estimated Primary Completion Date: January 9, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPC1063 (Ozanimod) Drug: RPC1063
Other Name: Ozanimod

Detailed Description:
This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.
  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:

  • Crohn's disease (CD) confirmed by endoscopy and histology
  • Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
  • Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy

Key Exclusion Criteria:

  • Diagnosis of ulcerative colitis or indeterminate colitis
  • Known strictures/stenosis leading to symptoms of obstruction
  • Current stoma or need for ileostomy or colostomy
  • 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 or known macular edema
  • History of colonic dysplasia
  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: NCT02531113

  Show 28 Study Locations
Sponsors and Collaborators
Celgene
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02531113     History of Changes
Other Study ID Numbers: RPC01-2201
Study First Received: August 20, 2015
Last Updated: August 31, 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 21, 2017