350 Participants Needed

Guselkumab for Crohn's Disease

(GRAVITI Trial)

Recruiting at 497 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Guselkumab, also known as Tremfya or CNTO1959, has been evaluated for safety in clinical trials for Crohn's disease and other conditions. The trials showed that it is generally well-tolerated, with most side effects being mild, indicating a good safety profile.12345

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

JR

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guselkumab or placebo injections subcutaneously to evaluate efficacy and safety in Crohn's disease

12 weeks
Regular visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 weeks
Periodic visits for monitoring adverse events and clinical outcomes

Treatment Details

Interventions

  • Guselkumab
Trial Overview 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.
Participant Groups
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:
  • Moderate to severe plaque psoriasis
  • Psoriatic arthritis
  • Moderately to severely active ulcerative colitis
🇪🇺
Approved in European Union as Tremfya for:
  • 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

Trials
1,022
Recruited
6,408,000+
Giacomo Salvadore profile image

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar profile image

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

Adalimumab, a fully human monoclonal anti-TNF alpha antibody, has been shown to be clinically effective in treating severe, active Crohn's disease, providing rapid action and maintaining efficacy over 3 years in both treatment-naïve and previously treated patients.
The treatment is associated with a reduction in hospitalization rates and improved quality of life, while its safety profile is comparable to other TNF alpha inhibitors, with low immunogenicity and rare allergic reactions, highlighting the importance of careful patient screening during treatment.
[Adalimumab for the treatment of Crohn's disease - consensus paper of the Working Group "chronic inflammatory bowel diseases" of the Austrian Society for Gastroenterology and Hepatology].Reinisch, W., Haas, T., Kaser, A., et al.[2015]
Immunosuppressant and biologic therapies for Crohn's disease and ulcerative colitis can lead to a range of adverse events, from mild symptoms to serious complications like infections and cancers, highlighting the importance of careful monitoring.
The review emphasizes the need for healthcare providers to engage in personalized risk-benefit discussions with patients regarding these therapies, considering individual risk factors to optimize treatment outcomes.
Adverse events in IBD therapy: the 2018 update.Quezada, SM., McLean, LP., Cross, RK.[2019]
Fontolizumab, an anti-interferon gamma antibody, was generally well tolerated in a study of 45 patients with moderate to severe Crohn's disease, with only mild adverse effects reported at higher doses.
While no significant differences in clinical activity were observed between fontolizumab and placebo, the highest dose (4.0 mg/kg) showed a notable reduction in Crohn's disease severity and inflammation markers, suggesting potential biological activity.
A dose escalating, placebo controlled, double blind, single dose and multidose, safety and tolerability study of fontolizumab, a humanised anti-interferon gamma antibody, in patients with moderate to severe Crohn's disease.Reinisch, W., Hommes, DW., Van Assche, G., et al.[2022]

References

[Adalimumab for the treatment of Crohn's disease - consensus paper of the Working Group "chronic inflammatory bowel diseases" of the Austrian Society for Gastroenterology and Hepatology]. [2015]
Adverse events in IBD therapy: the 2018 update. [2019]
A dose escalating, placebo controlled, double blind, single dose and multidose, safety and tolerability study of fontolizumab, a humanised anti-interferon gamma antibody, in patients with moderate to severe Crohn's disease. [2022]
Adalimumab safety in global clinical trials of patients with Crohn's disease. [2022]
The Efficacy and Safety of Biologic Drugs in the Treatment of Moderate-Severe Crohn's Disease: A Systematic Review. [2023]
Medical management of Crohn's disease. [2019]
The state of the art on treatment of Crohn's disease. [2019]
IBD: Adalimumab for ulcerative colitis— is the glass half empty or half full? [2021]
Systematic Review and Network Meta-Analysis: Comparative Efficacy and Safety of Biosimilars, Biologics and JAK1 Inhibitors for Active Crohn Disease. [2021]
gp130 blockade to NOD off Crohn's disease. [2021]
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