To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2020-05-26
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Budesonide; Mesalamine

Criteria

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