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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435992
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE April 24, 2015
First Posted Date  ICMJE May 6, 2015
Last Update Posted Date October 22, 2019
Actual Study Start Date  ICMJE June 17, 2015
Estimated Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Current 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02435992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
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 3 separate cohorts (Cohort 1 and Cohort 2 for adults, Cohort 3 for adolescents). Patients from Cohort 1, 2, and 3 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1, 2, and 3 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2015)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 28, 2021
Estimated Primary Completion Date June 29, 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)
  • Male or female adolescent patients aged 12 to < 18 years (at screening) with a body weight greater than or equal to 45 kg
  • 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 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Celgene True North Study True North Study 1-844-266-9299 truenorth@quintiles.com
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 October 2019

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