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

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Clinicaltrials.gov identifier NCT02531126

Recruitment Status Recruiting

First Posted August 24, 2015

Last update posted February 26, 2020

Study Description

Brief summary:

The purpose of this study is to determine the long-term safety of RPC1063 for the treatment of all patients with moderate to severe Ulcerative Colitis (UC) as well as the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC. Additionally, to determine the long-term efficacy of RPC1063 for the treatment of adolescent patients with moderate to severe UC.

  • Condition or Disease:Ulcerative Colitis
  • Intervention/Treatment: Drug: RPC1063
  • Phase: Phase 3
Detailed Description

The trial is an open label extension study. Eligible patients from the RPC01-3101 and RPC01-202 trials will have the option to enroll in this trial to receive study medication until the end of 2021 or until marketing approval of RPC1063 for UC is obtained in their country, or until the Sponsor discontinues the development program, whichever comes first.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 890 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
  • Actual Study Start Date: December 2015
  • Estimated Primary Completion Date: February 2022
  • Estimated Study Completion Date: February 2022
Arms and interventions
Arm Intervention/treatment
Experimental: RPC0163 (Ozanimod)
Drug: RPC1063
Outcome Measures
  • Primary Outcome Measures: 1. Evaluate the long-term safety of RPC1063 for the treatment of all patients with moderate to severe UC. [ Time Frame: Up to 6 years ]
    Number of participants with adverse events
  • 2. Evaluate the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC. [ Time Frame: Up to 6 years ]
    Assessed by Mayo component sub scores which are the rectal bleeding subscore, stool frequency subscore, physician global assessment subscore, and the endoscopy subscore. Each subscore has a range of 0-3 points. The primary endpoint analysis will be based on the 9-point Mayo score consisting of RBS, SFS, and endoscopy score with a range of 0-9 points
Eligibility Criteria
  • Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Aged 18 to 75 years (at screening for Cohorts 1 and 2)

- Male of Female adolescent patients aged 12 to or = 45kg (Cohort 3)

- Ulcerative colitis confirmed on endoscopy

- Moderately to severely active ulcerative colitis (Mayo score 6-12)

- Currently receiving treatment with aminosalicylates, 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 evidenced by:

- Physician judgement 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 Crohn's disease, indeterminate colitis, or the presence of a fistula
consistent with Crohn's disease 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 known macular edema

- Pregnancy, lactation, or a positive serum B-hCG measured during screening

Contacts and Locations
Contacts

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

Locations
Show 269 Study Locations
Sponsors and Collaborators

Celgene

Investigators

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

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT02531126 History of Changes
  • Other Study ID Numbers: RPC01-3102, 2015-001600-64, U1111-1218-0284
  • First Posted: August 24, 2015 Key Record Dates
  • Last Update Posted: February 26, 2020
  • Last Verified: February 2020
  • Additional relevant MeSH terms: Colitis, Ulcerative
    Ulcer
    Colitis