A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

Overview

About this study

To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

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 Crohn's disease (CD) for at least 90 days.
  2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
  3. Subject inadequately responded to or experience intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Exclusion Criteria:

  1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
  2. Subject who has had surgical bowel resections in the past 6 months or is planning resection.
  3. Subjects with an ostomy or ileoanal pouch.
  4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
  5. Subject who has short bowel syndrome.
  6. Subject with 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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