A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with moderate to severe Crohn’s disease who have either failed treatment or not responded well enough to treatment with medicines that decrease the immune response.
The purpose of the study is to evaluate the effectiveness of a drug called ustekinumab in treating Crohn’s disease. Ustekinumab (also called Stelara) is a type of drug called a monoclonal antibody. It blocks two proteins that cause inflammation. Ustekinumab is FDA-approved for treating psoriasis but is not approved for treating Crohn’s disease; therefore its use in this study is experimental.
Study participants will be randomly assigned to one of three treatment groups:
- Group 1: Ustekinumab 130 mg
- Group 2: Ustekinumab at a higher dose adjusted for a participant’s weight
- Group 3: Placebo (an inactive substance that looks like ustekinumab but does not contain medication)
Participants in each treatment group will receive a single IV infusion of ustekinumab or placebo at the first study visit. After receiving the ustekinumab/placebo infusion, participants will remain in the study for 8 weeks. After 8 weeks, participants who are still eligible will have the opportunity to move onto another study of longer duration. Participants who receive placebo in the current study will have the opportunity to receive ustekinumab in the new study.
Disease Status and/or Stage
Moderate to Severe Crohn's Disease
Sponsor
Janssen
Key Eligibility
- Men and women age 18 and older
- Diagnosed with Crohn's disease
- Have not responded to conventional treatment for Crohn's disease
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- IBD Center
- (212) 746-5077
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
