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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
Must not have
History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease
Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 and week 48
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or had complications related to perianal disease.
Select...
I have a long-term or recurring infection.
Select...
I have complications from Crohn's disease that may need surgery.

Timeline

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
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Guselkumab
Ixekizumab
Guselkumab Post-Treatment Follow Up

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

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
Common treatments for Crohn's Disease include biologic therapies such as anti-TNF agents (e.g., infliximab, adalimumab), which block tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. Another class includes IL-23 inhibitors like Guselkumab, which target the interleukin-23 pathway, crucial in the inflammatory process of Crohn's Disease. Immunomodulators (e.g., azathioprine) suppress the immune response more broadly. These treatments are essential as they help reduce inflammation, manage symptoms, and induce and maintain remission, improving the quality of life for patients with Crohn's Disease.
Popular exclusionary diets for inflammatory bowel disease: the search for a dietary culprit.

Find a Location

Who is running the clinical trial?

Janssen-Cilag Ltd.Lead Sponsor
97 Previous Clinical Trials
48,252 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
~68 spots leftby Mar 2025