What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include biologics like Guselkumab, glucocorticoids, and 5-aminosalicylates. Biologics, such as Guselkumab, can cause side effects like increased risk of infections, injection site reactions, and potential allergic reactions. Glucocorticoids are associated with significant side effects including weight gain, osteoporosis, hypertension, and increased risk of infections. 5-aminosalicylates can cause gastrointestinal upset, headache, and rarely, kidney dysfunction. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease. Anti-TNF agents such as infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia) have been widely used and shown efficacy in inducing and maintaining remission. Ustekinumab (Stelara), an IL-12/23 inhibitor, has also been approved for moderate to severe Crohn's Disease, offering a mechanism of action similar to guselkumab, which targets IL-23. Additionally, vedolizumab (Entyvio), an integrin receptor antagonist, has been approved for patients who have not responded to other treatments. These biologics represent significant advancements in the management of Crohn's Disease.

What other types of research exist?

Promising novel alternatives to Guselkumab for Crohn's Disease patients include Ustekinumab (an IL-12/23 inhibitor), Vedolizumab (an integrin receptor antagonist), and newer Janus kinase (JAK) inhibitors like Upadacitinib. These treatments have shown efficacy in clinical trials and offer different mechanisms of action that may benefit patients who do not respond to IL-23 inhibition.

← Back to Search

Monoclonal Antibodies

Guselkumab for Crohn's Disease (GRAVITI Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Crohn's disease (CD) of at least 3 months in duration

Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD)

Must not have

Complications of Crohn's disease that require surgical intervention or confound efficacy assessments

Unstable doses of concomitant Crohn's disease therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 260 weeks

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Guselkumab may cause side effects such as infections, injection site reactions, headaches, stomach pain, and possibly allergic reactions. It might also affect liver enzymes and blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have Crohn's disease complications needing surgery.

Select...

My Crohn's disease medication dose has been changing.

Select...

I have been diagnosed with ulcerative colitis or indeterminate colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 260 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 260 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 260 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Remission at Week 12

Endoscopic Response at Week 12

Secondary study objectives

Clinical Remission at Week 24

Clinical Response at Week 12

Patient-reported Outcome (PRO)-2 Remission at Week 12

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab Dose 1

2018

Completed Phase 2

~300

Guselkumab Dose 2

2018

Completed Phase 2

~300

Guselkumab Dose 3

2018

Completed Phase 1

~30

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Crohn's Disease include biologic therapies that target specific cytokines involved in the inflammatory process. Guselkumab, an IL-23 inhibitor, works by blocking the interleukin-23 pathway, which is crucial in the inflammatory response seen in Crohn's Disease. This helps reduce inflammation and maintain remission. Other biologics, such as anti-TNF agents (e.g., infliximab, adalimumab) and IL-12/23 inhibitors (e.g., ustekinumab), target tumor necrosis factor-alpha and interleukins 12 and 23, respectively. These treatments are essential for patients as they help control severe inflammation, reduce symptoms, and prevent complications, thereby improving the quality of life.