A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease

Inclusion Criteria:

• Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 monthsduration, with colitis, ileitis, or ileocolitis, confirmed in the past byradiography, histology, and/or endoscopy

• Have moderately to severely active CD, defined as a baseline Crohn's diseaseactivity index (CDAI) score of greater than or equal to (>=) 220 and less than orequal to (<=) 450, and either: a. Mean daily stool frequency (SF) count >3, based onthe unweighted CDAI component of the number of liquid or very soft stools or b. Meandaily abdominal pain (AP) score >1, based on the unweighted CDAI component of AP

• Have endoscopic evidence of active ileocolonic CD as assessed by central endoscopyreading at the screening endoscopy, defined as a screening simple endoscopic scorefor crohn's disease (SES-CD) score >=6 (or >=4 for participants with isolated ilealdisease), based on the presence of ulceration in at least 1 of the 5 ileocolonicsegments, resulting in the following specified ulceration component scores: a. aminimum score of 1 for the component of "size of ulcers"; and b. a minimum score of 1 for the component of "ulcerated surface"

• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urinepregnancy test at baseline

• Must sign an informed consent form (ICF) indicating that he or she understands thepurpose of, and procedures required for, the study and is willing to participate inthe study

Exclusion Criteria:

• Has complications of Crohn's disease such as symptomatic strictures or stenoses,short gut syndrome, or any other manifestation that might be anticipated to requiresurgery, could preclude the use of the CDAI to assess response to therapy, or wouldpossibly confound the ability to assess the effect of treatment with ustekinumab

• Has previously demonstrated lack of initial response (that is, primarynonresponders), responded initially but then lost response with continued therapy (that is, secondary nonresponders) to Vedolizumab

• Has a history of, or ongoing, chronic or recurrent infectious disease, including butnot limited to, chronic renal infection, chronic chest infection (example,bronchiectasis), recurrent urinary tract infection (example, recurrentpyelonephritis or chronic non-remitting cystitis), or open, draining, or infectedskin wounds or ulcers

• History of lymphoproliferative disease, including lymphoma, or signs and symptomssuggestive of possible lymphoproliferative disease, such as lymphadenopathy orsplenomegaly or monoclonal gammopathy of undetermined significance

• Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic,hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic,psychiatric, or metabolic disturbances, or signs and symptoms thereof