Last updated on July 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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