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Open-Label Extension of RPC1063 as Therapy 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: NCT02531126
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

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 Intervention/treatment Phase
Ulcerative Colitis Drug: RPC1063 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 890 participants
Allocation: N/A
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 2, 2015
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RPC0163 (Ozanimod) Drug: RPC1063
Other Name: Ozanimod




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



Information from the National Library of Medicine

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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 < 18 years (at screening) with a body weight > 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

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): NCT02531126


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

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: AnnKatrin Petersen, M.D., MSc. Celgene Corporation
Additional Information:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02531126    
Other Study ID Numbers: RPC01-3102
2015-001600-64 ( EudraCT Number )
U1111-1218-0284 ( Registry Identifier: WHO )
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
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