Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

a study on Inflammatory Bowel Disease

Summary

for people ages 12 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Details

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.

Keywords

Ulcerative Colitis Colitis Colitis, Ulcerative Ulcer RPC1063 RPC0163 (Ozanimod)

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego Medical Center accepting new patients
    La Jolla California La Jolla United States
  • Medical Associates Research Group, Inc. accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
http://www.truenorthstudy.com/
ID
NCT02531126
Phase
Phase 3
Study Type
Interventional
Last Updated