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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

Summary

This trial studies how well guselkumab works to treat Crohn's Disease in children after 12 weeks of therapy.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Percentage of Participants with Clinical Remission at Week 52
Secondary outcome measures
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

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
~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, 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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,173 Total Patients Enrolled
Clinical TrialStudy DirectorJanssen Research & Development, LLC
9 Previous Clinical Trials
2,150 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05923073 — Phase 3
Crohn's Disease Research Study Groups: Open-label maintenance phase: Guselkumab SC, Open-label induction phase: Guselkumab Intravenously (IV), Double-blind maintenance phase: Guselkumab SC or Guselkumab SC and Placebo SC, Open-label induction phase: Guselkumab Subcutaneously (SC)
Crohn's Disease Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT05923073 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05923073 — Phase 3
~80 spots leftby Oct 2027