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Currently, you can access the following clinical trials being conducted worldwide:

339,504 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/01/2020.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/01/2020.

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

Clinicaltrials.gov identifier NCT02435992

Recruitment Status Recruiting

First Posted May 6, 2015

Last update posted April 30, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Ulcerative Colitis
  • Intervention/Treatment: Drug: RPC1063
    Drug: Placebo
  • Phase: 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 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 Design
  • Study Type: Interventional
  • Estimated 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 2015
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: March 2021
Arms and interventions
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
  • Primary Outcome Measures: 1. Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 10 ]
    Induction Period
  • 2. Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 52 ]
    Maintenance Period
Eligibility Criteria
  • Ages Eligible for Study: 12 to 75 Years (Child, 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)

- 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

Contacts and Locations
Contacts

Contact: Celgene True North Study True North Study 1-844-266-9299 truenorth@quintiles.com

Locations
Show 373 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: AnnKatrin Petersen, M.D., MSc. Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT02435992 History of Changes
  • Other Study ID Numbers: RPC01-3101
  • First Posted: May 6, 2015 Key Record Dates
  • Last Update Posted: April 30, 2020
  • Last Verified: April 2020
  • Additional relevant MeSH terms: Colitis
    Colitis, Ulcerative
    Ulcer