A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

This study (CNTO1275CRD3002 or "UNITI-2") examines ustekinumab (an antibody medication that
inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical
except without the ustekinumab antibody) given intravenously (by an IV) in adults with
moderately to severely active Crohn's disease. Ustekinumab (also known as Stelara) is
approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis,
but this study will examine if ustekinumab can provide benefit in Crohn's disease and also
assess for any risks or side effects. Both the positive and negative outcomes of IV placebo
versus two different doses of IV ustekinumab will be tracked and compared over eight weeks,
in approximately 612 patients who have previously failed or were intolerant to
corticosteroids or immunomodulators (methotrexate, azathioprine, or 6-mercaptopurine) or are
dependent on corticosteroid medications. Patients enrolling in this study will be assigned to
one of the 3 treatment groups by chance (randomly, like rolling dice), and all will receive a
single IV administration of study agent at the first study visit (after the screening
period), and then will be asked to return for 3 additional visits through Week 8. Patients
who complete this study through the Week 8 visit and remain eligible can enter the
maintenance study (CNTO1275CRD3003 or "IM-UNITI"), where they will receive additional study
agent, including the administration of ustekinumab in patients who receive placebo in this
study and have not had improvement in their Crohn's disease. Patients who do not enter the
CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after
they received study agent when they entered into this study at the Week 0 visit. .All
patients will receive a single intravenous (IV) administration of study drug (placebo or
ustekinumab) at the start of the study.There are 3 treatment groups in this study: Group 1:
Placebo; Group 2: ustekinumab 130 mg, Group 3: weight-range based ustekinumab doses
approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85
kg), and 520 mg (weight > 85 kg).

Inclusion Criteria:

- Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or
ileocolitis, confirmed at some time in the past by radiography, histology, or
endoscopy

- Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI)
score of >= 220 and <= 450, with confirmation of active inflammation

- Has failed conventional therapy as demonstrated by having received corticosteroids
and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a
history of failure to respond to or tolerate an adequate course of corticosteroids
and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is
corticosteroid dependent or has had a history of corticosteroid dependency AND Has not
previously demonstrated failure of or intolerance to 1 or more TNF-antagonist
therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria

- Have screening laboratory test results within protocol-specified parameters

Exclusion Criteria:

- Patients who have had any kind of bowel resection within 6 months

- Are pregnant or planning pregnancy (both men and women) while enrolled in the study or
for 20 weeks after receiving study agent

- Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks
before the first administration of study drug

- Patients with certain complications of Crohn's disease that would make it hard to
assess response to study drug

- Patients with a history of or ongoing chronic or recurrent infectious disease

- Patients who have previously received a biologic agent targeting IL-12 or IL-23,
including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)