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

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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

Tracking Information
First Submitted Date  ICMJE April 24, 2015
First Posted Date  ICMJE May 6, 2015
Results First Submitted Date  ICMJE June 25, 2021
Results First Posted Date  ICMJE September 1, 2021
Last Update Posted Date September 1, 2021
Actual Study Start Date  ICMJE June 17, 2015
Actual Primary Completion Date March 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2021)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2021)
  • 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
  • Percentage of Participants With Endoscopic Improvement at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants with endoscopic improvement at 10 weeks
  • Percentage of Participants With Mucosal Healing at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants with mucosal healing at 10 weeks
  • 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
  • Percentage of Participants With Endoscopic Improvement at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with endoscopic improvement at 52 weeks
  • 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
  • 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
  • Percentage of Participants With Mucosal Healing at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with Mucosal Healing at 52 weeks
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
Brief Summary The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: RPC1063
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: RPC1063 (Ozanimod)
    1mg, daily oral administration during Induction and Maintenance periods.
    Intervention: Drug: RPC1063
  • Placebo Comparator: Placebo
    Daily oral administration during Induction and Maintenance periods.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2020)
1012
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2015)
900
Actual Study Completion Date  ICMJE June 17, 2020
Actual Primary Completion Date March 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   Georgia,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Moldova, Republic of,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02435992
Other Study ID Numbers  ICMJE RPC01-3101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AnnKatrin Petersen, M.D., MSc. Celgene
PRS Account Celgene
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP