What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, particularly biologics like Guselkumab (IL-23 inhibition), include monoclonal antibodies such as infliximab and adalimumab. These treatments are associated with side effects including increased risk of infections (e.g., respiratory and urinary tract infections), potential development of malignancies, and immunogenicity leading to reduced efficacy over time. Other side effects may include injection site reactions, liver enzyme abnormalities, and metabolic issues. It is crucial to monitor patients regularly to manage these risks effectively.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Crohn's Disease, focusing on different inflammatory pathways. Guselkumab, an IL-23 inhibitor, is being studied for its efficacy in Crohn's Disease. Similar biologics include ustekinumab, which targets both IL-12 and IL-23 and has been approved for moderate to severe Crohn's Disease. Other biologics targeting TNF-alpha, such as infliximab, adalimumab, and certolizumab pegol, have also been approved and are widely used. Vedolizumab, which targets integrin α4β7, is another approved biologic for Crohn's Disease. These treatments represent a range of mechanisms aimed at controlling the inflammatory processes in Crohn's Disease.

What other types of research exist?

Promising, novel alternatives to Guselkumab for Crohn's Disease patients in 2024 include: <ol> <li>Ustekinumab (IL-12/23 inhibitor)</li> <li></li> </ol> Vedolizumab (integrin receptor antagonist) 3. Tofacitinib (JAK inhibitor) 4. Adalimumab (TNF inhibitor) 5. Infliximab (TNF inhibitor)

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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 up to week 48 and week 96

Awards & highlights

Pivotal Trial

Summary

This trial tests a medicine called guselkumab on adults with severe Crohn's disease who haven't responded to other treatments. The study will last over two years and will check both how well the medicine works and its safety. Guselkumab is already approved for treating other conditions like plaque psoriasis and psoriatic arthritis.

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.

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.

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.

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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:

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I have or had complications related to perianal disease.

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I have a long-term or recurring infection.

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I have complications from Crohn's disease that may need surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 48 and week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 48 and week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 48 and week 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants who Achieve Combined Fistula Remission at Week 24

Secondary study objectives

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

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. 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

~6080

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

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.