A Phase 3 Randomized Double-blind Placebo- and Active-controlled Parallel-group Multicenter Protocol to Evaluate the Safety and Efficacy of Guselkumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Crohn's Disease
  • Age: Between 18 years - 150 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.
    2. Have clinically active Crohn’s disease, defined as a baseline CDAI score =220 but =450 and either: a. Mean daily SF count > 3, based on the underweighted CDAI component of the number of liquid or very soft stools OR b.Mean daily AP score >1, based on the underweighted CDAI component of abdominal pain
    3. Prior or current medication for Crohn’s disease must include at least 1 of the following and additional criteria:

You may not be eligible for this study if the following are true:

    1. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses provided that there is no anticipated need for further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and no abscesses are currently identified.
    2. Has a draining (ie, functioning) stoma or ostomy
    3. Has previously received a biologic agent targeting IL-12/23 or IL-23, including but not limited to briakinumab, brazikinumab, fuselkumab, mirakizumab,(formerly LY2525623) and risankizumab.
    4. Currently has a malignancy or has a history of malignancy within 5 years before screening (with the recurrence for at least 3 months [defined as a minimum of 12 weeks] before the first study intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study intervention administration).
    5. Has had a BCG vaccination within 12 months of screening.

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