A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease (UNITI-2)

Overview

About this study

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

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:

  • Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
  • Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of ≥ 220 and ≤ 450, with confirmation of active inflammation
  • Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
  • Have screening laboratory test results within protocol-specified parameters

Exclusion Criteria:

  • Patients who have had any kind of bowel resection within 6 months
  • Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
  • Patients who have received infliximab, adalimumab or certolizumab pegol ≤ 8 weeks before the first administration of study drug
  • Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
  • Patients with a history of or ongoing chronic or recurrent infectious disease
  • Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

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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