What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, particularly biologic therapies like guselkumab (targeting IL-23), ustekinumab (targeting IL-12/23), and anti-TNF agents, have several known side effects. These can include an increased risk of infections, nasopharyngitis, and injection site reactions. Ustekinumab specifically may cause headaches and a low rate of antibody formation against the drug. Anti-TNF agents can also lead to serious infections, including tuberculosis and fungal infections, and may increase the risk of certain cancers. Patients should discuss these potential side effects with their healthcare provider to make an informed decision about their treatment plan.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease, particularly monoclonal antibodies targeting specific interleukins. Ustekinumab, which targets both IL-12 and IL-23, is used for patients with moderate to severe Crohn's Disease, especially those who have not responded to other biologics. Other biologics include anti-TNF agents like infliximab, adalimumab, and certolizumab pegol, which target tumor necrosis factor-alpha (TNF-α). Vedolizumab, an integrin receptor antagonist, is also approved for this condition. These treatments aim to reduce inflammation and maintain remission in patients with Crohn's Disease.

What other types of research exist?

Promising, novel alternatives to Guselkumab for Crohn's Disease patients include Ustekinumab (targets IL-12/23), Vedolizumab (integrin receptor antagonist), and Tofacitinib (Janus kinase inhibitor). These agents have shown efficacy and safety in clinical trials for Crohn's Disease and offer different mechanisms of action compared to Guselkumab.

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Monoclonal Antibodies

Guselkumab for Pediatric Crohn's Disease (MACARONI-23 Trial)

Phase 3

Recruiting

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at weeks 16, 24, 36, 48 and 52

Awards & highlights

Pivotal Trial

Summary

This trial tests guselkumab, an anti-inflammatory medication, on children with Crohn's Disease who initially responded well to it. The goal is to see if the benefits last over several months by reducing immune system activity. Guselkumab has shown effectiveness in treating moderate-to-severe psoriasis and psoriatic arthritis.

Who is the study for?

This trial is for children with moderately to severely active Crohn's Disease, confirmed by clinical and endoscopic criteria. They must have a PCDAI score >30 and an SES-CD score >=6 (or >=4 for isolated ileal disease). Participants should have tried other treatments without success or could not tolerate them. Those who've had recent bowel surgery or have complications like abscesses or strictures can't join.

What is being tested?

The study tests the effectiveness of Guselkumab, a medication, in treating Crohn's Disease in kids over one year. It checks if those who responded well at Week 12 continue to benefit at Week 52. The trial includes a comparison group receiving a placebo to measure Guselkumab's true effects.

What are the potential side effects?

While specific side effects are not listed here, similar medications often cause immune system reactions, infections, injection site reactions, and potential allergic responses. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at weeks 16, 24, 36, 48 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at weeks 16, 24, 36, 48 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 16, 24, 36, 48 and 52 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 Endoscopic Response at Week 52

Percentage of Participants with Clinical Remission at Week 52

Secondary study objectives

Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52

Change from Baseline in Body Weight at Weeks 12, 24, and 52

Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52

+16 more

Awards & Highlights

Pivotal Trial

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Open-label maintenance phase: Guselkumab SCExperimental Treatment1 Intervention

Week 12 non-responders will enter open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.

Group II: Open-label induction phase: Guselkumab Subcutaneously (SC)Experimental Treatment1 Intervention

Participants will receive guselkumab dose SC based on their BW during the 12-week open-label induction phase.

Group III: Open-label induction phase: Guselkumab Intravenously (IV)Experimental Treatment1 Intervention

Participants will receive guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.

Group IV: Double-blind maintenance phase: Guselkumab SC or Guselkumab SC and Placebo SCExperimental Treatment2 Interventions

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive a guselkumab dose SC based on their BW or a guselkumab dose SC based on their BW and placebo SC up to Week 48.

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

Do I qualify?Apply below to find out

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, particularly biologic agents, work by targeting specific components of the immune system to reduce inflammation. Guselkumab, a monoclonal antibody, targets interleukin-23 (IL-23), a cytokine involved in the inflammatory process. Other biologics, such as infliximab and adalimumab, inhibit tumor necrosis factor-alpha (TNF-α), another key inflammatory mediator. These targeted therapies are important for Crohn's Disease patients as they can provide more effective and personalized treatment options, potentially improving outcomes and minimizing side effects.

Review article: biological agents in the treatment of Crohn's disease.