A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Condition: Crohn's Disease; Inflammatory Bowel Disease; IBD; Colitis
MeSH terms: Crohn Disease; Colitis; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study (UNITI-2) will compare the effects (both positive and negative) of an initial
      treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely
      active Crohn's disease.
    

Detailed description: 
      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).
    

Intervention name(s): Group 1: Placebo; Group 2 ustekinumab 130 mg; Group 3: ustekinumab approximately 6 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Form=solution for injection, route=intravenous use, in a single dose.; Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.; Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.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).
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ustekinumab; moderately to severely active Crohn's Disease; Stelara; IBD; colitis; crohn; UNITI; Crohn's