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NCT05347095 · ClinicalTrials.gov registry record · Phase 3

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

A Phase 3 study of Fistulizing Crohns Disease and Perianal Crohns Disease, sponsored by Janssen-Cilag.

Active
Registry status
Phase 3
Development phase
288
Enrollment target
20
Study locations

NCT05347095 is a Phase 3 study of Fistulizing Crohns Disease and Perianal Crohns Disease that is active but no longer recruiting, run by Janssen-Cilag. The registered enrollment target is 288 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT05347095, a Phase 3 study of Fistulizing Crohns Disease and Perianal Crohns Disease, is active but no longer recruiting, sponsored by Janssen-Cilag.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
288 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

Interventions

  • DRUG Placebo
  • DRUG Guselkumab

Study Locations (20)

Other

  • Flinders Medical Centre - Adelaide
  • St Vincent's Hospital - Melbourne - Fitzroy
  • Liverpool Hospital - Liverpool
  • Fiona Stanley Hospital - Murdoch
  • Royal Prince Alfred Hospital - Newtown

Florida

  • University of Miami - Miami
  • Gastroenterology Group Of Naples - Naples
  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando - Orlando

Kentucky

  • University of Kentucky Chandler Medical Center - Lexington
  • University of Louisville - Louisville

Tennessee

  • Gastro One - Germantown
  • Vanderbilt University Medical Center - Nashville

Alabama

  • University of Alabama at Birmingham - Birmingham

Connecticut

  • Yale University - New Haven

Kansas

  • Kansas University Medical Center - Kansas City

Missouri

  • Washington University School Of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 288 participants
Start Date 2022-09-27
Est. Completion 2027-03-25
Phase Phase 3

Sponsor

Janssen-Cilag

4 total trials

What the Registry Record Tells You About NCT05347095

The ClinicalTrials.gov registry entry for NCT05347095 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen-Cilag, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Fistulizing Crohns Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05347095 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Florida, Kentucky.

Frequently Asked Questions

What is clinical trial NCT05347095 about?

NCT05347095 is a clinical study titled "A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease". The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

What is the current status of trial NCT05347095?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2022-09-27. Estimated completion is 2027-03-25.

What conditions does trial NCT05347095 study?

This clinical trial studies the following conditions: Fistulizing Crohns Disease, Perianal Crohns Disease.

What interventions are being tested in trial NCT05347095?

The interventions under investigation include: Placebo (DRUG), Guselkumab (DRUG).

Who is sponsoring clinical trial NCT05347095?

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

Where is trial NCT05347095 being conducted?

This trial has 20 study locations across Alabama, Connecticut, Florida, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.