Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis

Overview

About this study

To evaluate safety and efficacy of two dosing regimens in achieving clinical remission at Week 8 in subjects with moderately to severely active Ulcerative Colitis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
  2. 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.

Exclusion Criteria:

  1. Subject with Crohn's disease (CD) or indeterminate colitis (IC).
  2. Current diagnosis of fulminant colitis and/or toxic megacolon.
  3. Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
  4. Chronic recurring infections or active Tuberculosis (TB).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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