Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2019-11-11
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.

• Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.

Exclusion Criteria:

• Subject with Crohn's disease (CD) or indeterminate colitis (IC).

• Current diagnosis of fulminant colitis and/or toxic megacolon.

• Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.

• Chronic recurring infections or active tuberculosis (TB).