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Monoclonal Antibodies

Guselkumab for Crohn's Disease (FUZION CD Trial)

Phase 3

Recruiting

Research Sponsored by Janssen-Cilag Ltd.

Eligibility Criteria Checklist

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

Must have

Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results

Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 and week 48

Awards & highlights

FUZION CD Trial Summary

This trial evaluates whether the drug guselkumab is effective in treating Crohn's disease patients with fistulizing, perianal symptoms, and assesses the safety of the drug.

Who is the study for?

This trial is for individuals with Crohn's disease who've had it for at least 3 months and have at least one active draining perianal fistula. They must be new to biologic treatments or not responding well to current therapies. People with severe luminal disease, rectovaginal fistulas, ongoing infections, or complications that could need surgery can't join.Check my eligibility

What is being tested?

The study is testing the effectiveness of a drug called Guselkumab in treating fistulizing, perianal Crohn's disease compared to a placebo. It aims to see if this medication can help manage symptoms better than no treatment.See study design

What are the potential side effects?

While the specific side effects are not listed here, Guselkumab may cause immune system reactions since it targets certain proteins involved in inflammation which could lead to infection risks and other potential immune-related issues.

FUZION CD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have at least one active draining fistula due to Crohn's disease, confirmed by MRI.

Select...

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

FUZION CD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 and week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 and week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants who Achieve Combined Fistula Remission at Week 24

Secondary outcome measures

Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48

Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48

Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48

+35 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323

Injection site reaction

Upper respiratory tract infection

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab

Guselkumab

Ixekizumab Post-Treatment Follow Up

Guselkumab Post-Treatment Follow Up

FUZION CD Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3: PlaceboExperimental Treatment2 Interventions

Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.

Group II: Group 2: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.

Group III: Group 1: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~5990

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen-Cilag Ltd.Lead Sponsor

96 Previous Clinical Trials

48,024 Total Patients Enrolled

Janssen-Cilag Ltd. Clinical TrialStudy DirectorJanssen-Cilag Ltd.

18 Previous Clinical Trials

12,873 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05347095 — 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: NCT05347095 — Phase 3

Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05347095 — Phase 3

Frequently Asked Questions

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

Are we currently looking for participants for this experiment?

"The trial, which is still recruiting patients, was originally posted on September 27th, 2020 and the most recent update was on November 3rd, 2020."

Answered by AI

How many people have been recruited for this clinical research project?

"In order to move forward, this clinical trial requires 280 willing participants that match the given inclusion criteria. Patients that are interested can look into participating at Atlanta Gastroenterology Associates located in Atlanta, Georgia or Digestive Disease Specialists Inc. in Oklahoma City, Oklahoma."

Answered by AI

Has Guselkumab received official sanctioning from the FDA?

"There is some data supporting the efficacy of Guselkumab and multiple rounds of data supporting its safety, so our team at Power has given it a score of 3."

Answered by AI

At how many different medical facilities can patients participate in this trial?

"There are presently 20 sites where this clinical trial is underway. The locations are in Atlanta, Oklahoma City, New Haven, and17 other locations. If you choose to participate in this trial, try and select the clinic that is closest to your location to cut down on travel time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

2022. "A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05347095.