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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 109 weeks
Awards & highlights

GRAVITI Trial Summary

This trial will test whether the drug guselkumab is effective and safe for people with 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.Check my eligibility
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.See study design
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.

GRAVITI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Crohn's disease for at least 3 months.
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I have moderate to severe Crohn's disease based on specific health scores.

GRAVITI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 109 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 109 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Remission at Week 12
Endoscopic Response at Week 12
Secondary outcome measures
Clinical Remission at Week 24
Clinical Response at Week 12
Patient-reported Outcome (PRO)-2 Remission at Week 12
+1 more

GRAVITI 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
~240
Guselkumab Dose 2
2018
Completed Phase 2
~240
Guselkumab Dose 3
2018
Completed Phase 1
~30

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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
979 Previous Clinical Trials
6,384,770 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
748 Previous Clinical Trials
3,960,348 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05197049 — Phase 3
Crohn's Disease Research Study Groups: Group 3: Placebo, Group 1: Guselkumab, Group 2: Guselkumab
Crohn's Disease Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT05197049 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05197049 — Phase 3
~102 spots leftby Jun 2025