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NCT06408935 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Crohn's Disease, sponsored by Janssen-Cilag.

Recruiting
Registry status
Phase 3
Development phase
112
Enrollment target
20
Study locations

NCT06408935 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Janssen-Cilag. The registered enrollment target is 112 participants, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT06408935, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Janssen-Cilag.

RECRUITING
Registry status
Phase 3
Development phase
112 participants
Enrollment target
20
Study locations

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

Crohn's Disease

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

4 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, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (95% lower). The listed sponsor is Janssen-Cilag, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT06408935 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Illinois.

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.

What interventions are being tested in trial NCT06408935?

The interventions under investigation include: Guselkumab (DRUG).

Who is sponsoring clinical trial NCT06408935?

This trial is sponsored by Janssen-Cilag, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.