Trial Information

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

This study (CNTO1275CRD3001 or "UNITI-1") 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 who previously did not respond to, lost
response to, or could not tolerate TNF-antagonist medications (specifically, infliximab,
adalimumab or certolizumab pegol). 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 703 patients. 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 (either placebo or
ustekinumab) at the first (week 0) visit when they enter the study.There are 3 treatment
groups: 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).