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

Ferring

Status and phase: Completed; Phase 3

Conditions: Colitis, Ulcerative

Treatments: Drug: Budesonide (9 mg); Drug: Mesalazine (3,600 mg); Drug: Budesonide (6 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03412682

000234

Details and patient eligibility

About

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.

Enrollment: 274 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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274 participants in 3 patient groups

Budesonide (6 mg)

Experimental group

Treatment:

Drug: Budesonide (6 mg)

Budesonide (9 mg)

Experimental group

Treatment:

Drug: Budesonide (9 mg)

Mesalazine (3,600 mg)

Active Comparator group

Treatment:

Drug: Mesalazine (3,600 mg)