NCT03412682

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

A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Budesonide (6 mg)	Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
DRUG	Budesonide (9 mg)	Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
DRUG	Mesalazine (3,600 mg)	Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.

Timeline

• Start date: 2018-03-02
• Primary completion: 2020-05-11
• Completion: 2020-05-26
• First posted: 2018-01-26
• Last updated: 2020-06-18

Locations

72 sites across 1 country: Japan