The objective of this study is to evaluate the efficacy and safety of an active drug compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
From 18 Years to 75 Years.
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's
disease (SES-CD) on an endoscopy confirmed by a central reader.
- Demonstrated an inadequate response or intolerance to one or more conventional and/or
biologic therapies (Oral locally acting steroids, Intravenous or oral corticosteroids,
Immunosuppressants), in the opinion of the investigator.
Note: Participants who have had inadequate response or intolerance to conventional therapy
who have received prior biologic may be enrolled; however, participants must have
discontinued the biologic for reasons other than inadequate response or intolerance (e.g.,
change of insurance, well controlled disease).
- If female, participant must meet the contraception recommendations.
- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
corticosteroids or methotrexate (MTX).
- Participant with the following ongoing known complications of CD: abscess (abdominal
or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or
any other manifestation that might require surgery while enrolled in the study.
- Participant with ostomy or ileoanal pouch.
- Participant diagnosed with conditions that could interfere with drug absorption
including but not limited to short gut or short bowel syndrome.
- Screening laboratory and other analyses show abnormal results.