Study to Evaluate Guselkumab vs. Stelara vs. Placebo in Participants with Moderately to Severely Active Crohn's Disease (H-44128)

What is the purpose of this study?

The purpose of this study is to Evaluate the Efficacy and Safety of Guselkumab vs. Stelara Vs. Placebo in Participants with Moderately to Severely Active Crohn's Disease. Guselkumab is currently approved in the United States (US), European Union (EU), and Canada for the treatment of moderate to severe plaque psoriasis. This is a 48 week study. 

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

Demonstrated inadequate response or failure to tolerate conventional therapy (corticosteroids, AZA, 6-MP, MTX) OR biologic 

No prior treatment with Stelara, preferred.

Minimal Exposure to Stelara, Eligible- Must meet the Following Criteria

o No more than one infusion treatment with Stelara

o No more than one subcutaneous dose of Stelara 8 weeks after the single Infusion

o Demonstrated an inadequate response to, or have failed to tolerate Stelara are ineligible

No current strictures or stenoses, short gut syndrome or manifestations that may require surgery

Willing to return every 4 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, Chest X-Ray, Colonoscopy (2 times throughout the study), infusion and subcutaneous injections. 

Will I get placed?

There are 5 treatment groups in this study, 2 of the study medication, 2 stelara, 1 placebo. The Ratio is 1:1:1:1:1. In the event you are assigned placebo, your study team will not be aware. If assigned placebo and you are non-responsive during the study at week 12, you will be reassigned to receive Stelara from Week 12 - 44.

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