Ground Truth
Inclusion Criteria:Have Crohn's disease (CD) 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 endoscopyHave moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)Have screening laboratory test results within the protocol specified parametersA female participant of childbearing potential must have a negative urine pregnancy test result at screening and baselineDemonstrated intolerance or inadequate response to conventional or to biologic therapy for CDExclusion Criteria:Current diagnosis of ulcerative colitis or indeterminate colitisHas complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestationUnstable doses of concomitant Crohn's disease therapyReceipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocolAny medical contraindications preventing study participation
Prediction
Inclusion Criteria:Have Crohn's disease (CD) 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 endoscopyHave moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)Have screening laboratory test results within the protocol specified parametersA female participant of childbearing potential must have a negative urine pregnancy test result at screening and baselineDemonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Global Co-primary Endpoints:
- Clinical remission at Week 48 and endoscopic response at Week 48 in the same participant
Regional Co-primary Endpoints:
- Clinical remission at Week 12 and endoscopic response at Week 12
Major Secondary Endpoints (Global and Regional):
- Corticosteroid-free clinical remission at Week 48
- Endoscopic response at Week 48
- Clinical remission at Week 48 and endoscopic response at Week 48 in the same participant
Exclusion Criteria:Current diagnosis of ulcerative colitis or indeterminate colitisHas complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestationUnstable doses of concomitant Crohn's disease therapyReceipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocolPrior exposure to p40 inhibitors or p19 inhibitorsAny medical contraindications preventing study participation