A Study to Evaluate the Safety and Effectiveness of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of continuing ustekinumab as a subcutaneous (injection) maintenance therapy in patients with moderately to severely active ulcerative colitis (UC) who have demonstrated a clinical response to an induction treatment with IV ustekinumab.

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:

  • Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
  • Has moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12, including a screening endoscopy subscore of the Mayo score ≥ 2 as determined by a central reading of the video endoscopy
  • Has received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and has a documented history of failure to respond to or tolerate such treatment
  • OR has not had biologic therapy (TNF antagonists or vedolizumab)
  • Has received biologic therapy but has not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and has a prior or current UC medication history that includes at least 1 of the following
    • Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) 
    • History of failure to respond to, or tolerate either oral or IV corticosteroids or immunomodulators (6-MP or AZA)
    • History of corticosteroid dependence (an inability to successfully taper corticosteroids without a return of the symptoms of UC)
  • Before the first administration of study agent vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks

 

Exclusion Criteria

  • Has severe extensive colitis and is at imminent risk of colectomy
  • Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon
  • Presence of a stoma or history of a fistula
  • History of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
  • History of colonic mucosal dysplasia.
    • Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia"

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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