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

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.
 
ClinicalTrials.gov Identifier: NCT02435992
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : September 1, 2021
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: RPC1063 Drug: Placebo Phase 3

Detailed Description:
The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : June 17, 2015
Actual Primary Completion Date : March 27, 2020
Actual Study Completion Date : June 17, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants in Clinical Remission at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants that are in Clinical remission at 10 weeks

  2. Percentage of Participants in Clinical Remission at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants that are in Clinical remission at 52 weeks


Secondary Outcome Measures :
  1. Percentage of Participants With Clinical Response at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants that are in Clinical response at 10 weeks

  2. Percentage of Participants With Endoscopic Improvement at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants with endoscopic improvement at 10 weeks

  3. Percentage of Participants With Mucosal Healing at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants with mucosal healing at 10 weeks

  4. Percentage of Participants in Clinical Response at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants that are in Clinical response at 52 weeks

  5. Percentage of Participants With Endoscopic Improvement at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with endoscopic improvement at 52 weeks

  6. Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 [ Time Frame: At 52 Weeks ]
    Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10

  7. Percentage of Participants With Corticosteroid Free Remission at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with corticosteroid free remission at 52 weeks

  8. Percentage of Participants With Mucosal Healing at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with Mucosal Healing at 52 weeks

  9. Percentage of Participants With Durable Clinical Remission at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with durable clinical remission at 52 weeks


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Aged 18 to 75 years (at screening for Cohort 1 and 2)
  • UC confirmed on endoscopy
  • Moderately to severely active UC (May score 6-12)
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide
  • Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria:

  • Have severe extensive colitis as evidence by:
  • Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
  • Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
  • Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, 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 or unknown macular edema
  • Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
Contacts and Locations
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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): NCT02435992


Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: AnnKatrin Petersen, M.D., MSc. Celgene
  Study Documents (Full-Text)

Documents provided by Celgene:
Study Protocol  [PDF] July 26, 2019
Statistical Analysis Plan  [PDF] June 18, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02435992    
Other Study ID Numbers: RPC01-3101
First Posted: May 6, 2015    Key Record Dates
Results First Posted: September 1, 2021
Last Update Posted: September 1, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Ozanimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs