About the VIVID-1 study

Study purpose

A clinical research study called the VIVID-1 study is currently enrolling patients ages 18–80 who have been diagnosed with Crohn’s disease (CD) for at least 3 months. The purpose of the VIVID-1 study is to evaluate whether treatment with mirikizumab (the investigational drug) is superior to ustekinumab (an already approved treatment) or placebo in patients with moderately to severely active CD.


Study design

The VIVID-1 study is a phase 3, multicenter, randomized, double-blind, double-dummy, parallel group, active- and placebo-controlled, treat-through design study. The primary objective is to evaluate the efficacy of the investigational drug compared to ustekinumab or placebo in patients with moderately to severely active CD who have an inadequate response to, loss of response to, or intolerance to conventional or biologic therapy for CD.

Participants will be randomized to receive the investigational drug, ustekinumab, or placebo in a ratio of 6:3:2, respectively.

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Study duration

The maximum total duration of study participation for each participant is 1 year and 5 months, and may include up to 19 appointments.

Main inclusion criteria

  • Be between the ages of 18 and 80, and diagnosed with CD for at least 3 months
  • Have moderately to severely active CD
  • Have an inadequate response to, loss of response to, or intolerance to conventional or biologic therapies for CD

Main exclusion criteria

  • Have a current diagnosis of ulcerative colitis or inflammatory bowel disease–unclassified
  • Have or suspected to have an abscess, stoma, ileoanal pouch, or ostomy
  • Have had a bowel resection within 6 months, or any kind of intra-abdominal surgery within 3 months of baseline
  • Not have had a bowel resection within 6 months, or any kind of intra-abdominal or extra-abdominal surgery within 3 months of baseline
  • Not have ever received any monoclonal antibodies binding IL-23

There are additional eligibility requirements, which the study doctor can explain to interested individuals.

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VIVID-1