for people ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Jonathan Terdiman



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


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.


Ulcerative Colitis Colitis Ulcer Colitis, Ulcerative RPC1063 RPC1063 (Ozanimod)


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


  • University of California at San Francisco (PARENT) accepting new patients
    San Francisco California 94115 United States
  • OM Research 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


accepting new patients
Start Date
Completion Date
Phase 3
Lead Scientist
Jonathan Terdiman
Study Type
Last Updated
August 7, 2018