Study to evaluate JNJ-64304500 vs. Ustekinumab vs. Placebo (H-40166)
What is the purpose of this study?
The purpose of this study is to evaluate safety and Efficacy of JNJ-64304500 vs. Ustekinumab vs. Placebo There are a total of 5 treatment arms. The assignment ration is 1:1:1:1:1. At week 12, patients previously assigned placebo will get the active medication.
Who is eligible to participate?
Moderately to severely active Crohn's Disease (of at least 3 months)
Confirmed Colitis, Ileitis, or Ileocolitis previously confirmed by radiography, histology or endoscopy
Must have previously failed or been intolerant to 1 or more approved biologic agents (Humira, Cimzia, Remicade, Entyvio, Stelara.) OR Never have had Biologic treatment, but failed immunomodulators (Azathioprine, 6-MP, Methotrexate) or corticosteroids.
No current strictures or stenoses, short gut syndrome or manifestations that may require surgery
Willing to return every 2, 6, and 8 weeks for study visits for duration of the study
The study coordinator will review medical and eligibility requirements by phone while setting up the first appointment. A consent form will be provided at the initial visit.
What is involved?
Subjects participating in the control project will be asked to make annual clinic visits at Baylor College of Medicine, located on the 8th floor of the McNair Building, 7200 Cambridge St, Houston, TX 77030. At the initial visit, a consent form explaining the study will be presented. Eligible subjects will be asked questions about their medical history and current medications. Subjects will also be given a brief physical exam (including vital signs) and routine blood work. The clinic visits will take about three and half hours. Once enrolled in the study, each subject will be asked to return monthly. Visits could include, vital signs, exams, brief questionnaires, blood work, stool samples, ECG, Colonoscopy (Three times throughout the study), infusion and subcutaneous injections.
Will I get placebo?
There is a chance of being assigned placebo. Your study doctor/team will not be aware of what you are assigned. However, at Week 12, if you have been assigned the placebo, you will be given the active medication for the remainder of the trial and the during the 52 week trial extension.
How much will this cost?
All research related procedures are FREE to you. Stipend for travel and time will also be included.
Who can I contact?
Alexys Nunn, Research Coordinator 713-798-3099
Joanna Cyrus David, Research Coordinator 713-798-1468