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Trial record 2 of 3 for:    RPC1063 AND moderate to severe ulcerative colitis

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

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ClinicalTrials.gov Identifier: NCT02435992
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: RPC1063 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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 17, 2015
Estimated Primary Completion Date : June 27, 2020
Estimated Study Completion Date : March 28, 2021

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years 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

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): NCT02435992


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

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Sponsors and Collaborators
Celgene
Investigators
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Study Director: AnnKatrin Petersen, M.D., MSc. Celgene

Additional Information:
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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: August 21, 2019
Last Verified: August 2019
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