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

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. Read our disclaimer for details. Identifier: NCT02531113
Recruitment Status : Active, not recruiting
First Posted : August 24, 2015
Last Update Posted : November 14, 2018
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Brief Summary:
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: RPC1063 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
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
Actual Study Start Date : October 9, 2015
Estimated Primary Completion Date : October 12, 2019
Estimated Study Completion Date : October 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: RPC1063 (Ozanimod) Drug: RPC1063
Other Name: Ozanimod

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02531113

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Sponsors and Collaborators

Responsible Party: Celgene Identifier: NCT02531113     History of Changes
Other Study ID Numbers: RPC01-2201
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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