This study is to evaluate the efficacy and safety of Mirikizumab in patients with moderately to severely active Crohn’s Disease.
Eligible participants must be male or female patients ?18 and ?80 years of age at the time of initial screening.
They must have had a diagnosis of CD or fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria
Participants will be randomized in a 6:3:2 ratio to receive, respectively:
- Mirikizumab 900 mg intravenously (IV) every 4 weeks (Q4W) for 3 doses, then 300 mg subcutaneously (SC) Q4W
- Ustekinumab ~6 mg/kg IV for one dose, then 90 mg SC every 8 weeks
- Placebo o When Period 1 concludes (Week 12), responders continue receiving placebo, and o Nonresponders (NR) at Week 12 will receive mirikizumab as described above.