Raw 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
Raw 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 endoscopy.
- Have 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 parameters.
- A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline.
- Demonstrated intolerance or inadequate response to conventional or biologic therapy for CD.
- Participants must be able to comply with the study protocol requirements.
Exclusion Criteria:
- Current diagnosis of ulcerative colitis or indeterminate colitis.
- Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation.
- Unstable doses of concomitant Crohn's disease therapy.
- Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol.
- Prior exposure to p40 inhibitors or p19 inhibitors.
- Any medical contraindications preventing study participation.
- Participants with anticipated events that align with updated protocol guidelines.
Processed Ground Truth
1. 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
Processed Prediction
1. 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 endoscopy.
2. Have 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).
3. Have screening laboratory test results within the protocol specified parameters.
4. A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline.
5. Demonstrated intolerance or inadequate response to conventional or biologic therapy for CD.
6. Participants must be able to comply with the study protocol requirements.
1. Current diagnosis of ulcerative colitis or indeterminate colitis.
2. Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation.
3. Unstable doses of concomitant Crohn's disease therapy.
4. Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol.
5. Prior exposure to p40 inhibitors or p19 inhibitors.
6. Any medical contraindications preventing study participation.
7. Participants with anticipated events that align with updated protocol guidelines.