Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

Inclusion Criteria:

• Males and females greater than or equal to 18 and less than or equal to 75 years of age at the Baseline visit.
• Diagnosis of ileal, colonic (including rectal), or ileocolonic CD confirmed using imaging technology or endoscopy not more than 6 years prior to Baseline.
• CDAI score of greater than or equal to 220 and less than or equal to 450 at the Baseline visit in subjects not receiving prednisone or equivalent at Baseline. CDAI score of greater than or equal to 200 and less than or equal to 450 at the Baseline visit if the subject is receiving prednisone less than or equal to 20 mg or equivalent for greater than or equal to 7 days before Baseline. CDAI score of greater than 150 and less than or equal to 450 at the Baseline visit if the subject is receiving prednisone greater than 20 mg or equivalent for greater than or equal to 7 days before Baseline
• Subjects or his/her legal representative have voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
• Adequate cardiac, renal and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires and physical examination results that do not indicate an abnormal clinical condition which would place the subject at undue risk and thus preclude subject participation in the study.
• Subjects must be able to self-inject and orally administer study medication or have a designee or Healthcare Professional who can assist

Exclusion Criteria:

• Previous or current biologic use for Crohn's disease or participation in a biologic study
• Previous or current use of immunomodulators (e.g., methotrexate, azathioprine, 6-mercaptopurine, JAK inhibitor, alpha-integrin) for Crohn's disease or participation in a Crohn's disease study with immunomodulator(s). Current use of immunomodulators for non-Crohn's disease at Baseline.
• Exclusion Criterion deleted in Amendment 3-"Receiving systemic corticosteroid for Crohn's disease at a dose of prednisone equivalent greater than to 20 mg per day or budesonide greater than 6 mg per day at Screening."
• Subjects with a poorly controlled medical condition such as: uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol
• Subjects with positive C. difficile stool assay at Screening.