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Summary

for people ages 18–75
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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

Details

The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in clinical response at the end of the Induction Period will proceed through to the Maintenance Period. Participation in these periods will be 52 weeks. Patients may also qualify to participate in an optional Open-Label Extension study.

Keywords

Ulcerative Colitis

Eligibility

For people ages 18–75

Key Inclusion Criteria:

  • Ulcerative Colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide

Key Exclusion Criteria:

  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or 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 macular edema
  • Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG)measured during Screening

Locations

  • High Desert Gastroenterology, Inc. accepting new patients
    Lancaster, California, 93534, United States
  • Facey Medical Foundation (Parent) accepting new patients
    Mission Hills, California, 91345, United States
  • Anaheim Clinical Trials accepting new patients
    Anaheim, California, 92801, United States
  • Alliance Clinical Research, LLC in progress, not accepting new patients
    Oceanside, California, 92056-4497, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
truenorthstudy.com
ID
NCT02435992
Phase
Phase 3
Lead Scientist
Jonathan Terdiman
Study Type
Interventional
Last Updated
July 1, 2017
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