Summary

for people ages 12-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Jonathan Terdiman

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. 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.

Keywords

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

Eligibility

You can join if…

Open to people ages 12-75

  • 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

You CAN'T join if...

  • 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

Locations

  • 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

Lead Scientist

  • Jonathan Terdiman
    Dr. Jonathan P. Terdiman is a Professor of Clinical Medicine and Surgery at UCSF. He earned his undergraduate degree from Princeton University in 1985 and his medical degree from the Columbia University College of Physicians and Surgeons in 1989.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
https://truenorthstudy.com/
ID
NCT02435992
Phase
Phase 3
Study Type
Interventional
Last Updated