Guselkumab for Crohn's Disease
(GRAVITI Trial)

Recruiting in Palo Alto (17 mi)

+497 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

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

I have Crohn's disease and didn't respond well to standard or biologic treatments.

I have been diagnosed with Crohn's disease for at least 3 months.

I have moderate to severe Crohn's disease based on specific health scores.

Exclusion Criteria

I have Crohn's disease complications needing surgery.

My Crohn's disease medication dose has been changing.

I have been diagnosed with ulcerative colitis or indeterminate colitis.

Participant Groups

The study tests three different doses of Guselkumab (a medication) against a placebo in patients with Crohn's Disease. The goal is to see which dose is most effective and safe for treating the symptoms and inflammation caused by the disease.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 2: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Group II: Group 1: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Group III: Group 3: PlaceboPlacebo Group1 Intervention

Participants will receive placebo injection subcutaneously.

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tremfya for: