Guselkumab for Crohn's Disease
(GRAVITI Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that you should not have unstable doses of your current Crohn's disease therapy. It's best to discuss your specific medications with the trial team.
Is Guselkumab safe for use in humans?
How does the drug Guselkumab differ from other treatments for Crohn's disease?
Guselkumab is unique because it targets a specific part of the immune system involved in inflammation, which is different from the commonly used treatments for Crohn's disease that often target tumor necrosis factor (TNF). This novel approach may offer an alternative for patients who do not respond well to existing therapies.678910
What is the purpose of this trial?
This trial is testing guselkumab, a medication that reduces inflammation, in patients with moderate to severe Crohn's disease. It works by blocking a protein called IL-23, which helps to lower inflammation in the body. Guselkumab is a monoclonal antibody that selectively inhibits IL-23 and has shown efficacy in treating inflammatory conditions like psoriasis and Crohn's disease.
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for people with moderate to severe Crohn's Disease who haven't had success with or can't tolerate standard treatments. They must have been diagnosed at least 3 months ago and meet specific criteria based on disease activity scores. Those with ulcerative colitis, indeterminate colitis, or complications needing surgery can't participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive guselkumab or placebo injections subcutaneously to evaluate efficacy and safety in Crohn's disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Guselkumab
Guselkumab is already approved in United States, European Union for the following indications:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires