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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
Select...
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
~280
Guselkumab Dose 2
2018
Completed Phase 2
~280
Guselkumab Dose 3
2018
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,958 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,555 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum dosage of Guselkumab that has been proven safe for patients?

"There is some evidence to support the efficacy of Guselkumab Dose 3, as this is a Phase 3 trial. Furthermore, its safety has been supported by multiple rounds of data, so it receives a 3 on our safety scale."

Answered by AI

At how many hospitals is this study taking place?

"One hundred different sites are involved in this clinical trial, with locations in Lubbock, Little Rock, Maitland, and many other places. To limit how much travelling is required, patients are encouraged to select a site close to their home."

Answered by AI

How many individuals are helping to test this medication?

"Yes, the trial is still open and recruiting patients. The original posting was on January 19th, 2022 and the listing was updated as recently as October 6th, 2022. They are trying to enroll 318 people total at 100 different locations."

Answered by AI

Why was this clinical trial originally designed and what goals does it seek to achieve?

"The main aim of this clinical study, which will be assessed after 12 weeks, is to observe clinical remission in participants. Other outcomes being measured include the percentage of participants experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation of study intervention. Clinical remission is defined as based on CDAI, and clinical response is defined as change from baseline in CDAI."

Answered by AI

How can interested parties sign up for this research project?

"Yes, the trial is still recruiting patients. It was originally posted on January 19th, 2022, with the most recent update on October 6th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
2022. "A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05197049.
All > Crohns Disease
~108 spots leftby Apr 2025
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