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RECRUITING Phase 3

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

NCT06408935 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

Conditions Studied

Interventions

  • DRUG Guselkumab

Study Locations (20)

Other

  • The Queen Elizabeth Hospital — Adelaide
  • Concord Repatriation General Hospital — Concord
  • Northern Hospital — Melbourne
  • Fiona Stanley Hospital — Murdoch
  • Mater Hospital Brisbane — South Brisbane
  • AZ Maria Middelares — Ghent
  • CHU de Liege — Liège
  • Vitaz — Sint-Niklaas
  • Cliged — Macaé
  • Instituto Mederi de Pesquisa e Saude — Passo Fundo
  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul — Porto Alegre
  • INTEGRAL Pesquisa e Ensino — Votuporanga
  • Nemocnice Ceske Budejovice a s — České Budějovice

California

  • Center for Colitis and Crohns Disease University of California — San Francisco

Illinois

  • The University of Chicago Medical Center (UCMC) — Chicago

Missouri

  • Washington University School Of Medicine — St Louis

South Carolina

  • Medical University of South Carolina — Charleston

Alberta

  • Foothills Hospital — Calgary

Ontario

  • Western University & London Health Sciences Centre — London

Quebec

  • Hopital du Sacre-Coeur de Montreal — Montreal

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2024-04-17
Est. Completion 2028-03-06
Phase Phase 3

Sponsor

Janssen-Cilag

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06408935

The ClinicalTrials.gov registry entry for NCT06408935 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen-Cilag, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention — of which Guselkumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06408935 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06408935 about?

NCT06408935 is a clinical study titled "Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients". The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

What is the current status of trial NCT06408935?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2024-04-17. Estimated completion is 2028-03-06.

What conditions does trial NCT06408935 study?

This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06408935?

The interventions under investigation include: Guselkumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06408935?

This trial is sponsored by Janssen-Cilag, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06408935 being conducted?

This trial has 20 study locations across California, Illinois, Missouri, South Carolina, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial