Last updated on September 2020

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active 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 (Pediatric) | Ulcerative Colitis
  • Age: Between 16 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis.
  • Diagnosis of ulcerative colitis in active phase of mild to moderate entity.
  • Female patients must fulfill at least one of the following criteria: Post-menopausal (women 45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period.
  • Male patients must agree to use medically approved contraception throughout the trial period.

Exclusion Criteria:

  • Patients with limited distal proctitis.
  • Patients with infectious colitis.
  • Patients with history of colectomy.
  • Patients with severe diseases in other organs and systems.
  • Evidence or history of toxic megacolon.
  • Women who wish to become pregnant during the trial period

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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