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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05347095

Public ClinicalTrials.gov record NCT05347095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 3:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05347095
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen-Cilag Ltd.
Industry
Enrollment
288 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 27, 2022 (Actual)
Primary completion
Mar 25, 2027 (Estimated)
Completion
Mar 25, 2027 (Estimated)
Last update posted
Sep 25, 2026

2022 – 2027

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Yale University New Haven Connecticut 06510 —
University of Miami Miami Florida 33136 —
Gastroenterology Group Of Naples Naples Florida 34102 —
AdventHealth Medical Group Blood & Marrow Transplant at Orlando Orlando Florida 32804 —
Kansas University Medical Center Kansas City Kansas 66160 —
University of Kentucky Chandler Medical Center Lexington Kentucky 40536 —
University of Louisville Louisville Kentucky 40202 —
Washington University School Of Medicine St Louis Missouri 63110 —
Mount Sinai School of Medicine New York New York 10029 —
Digestive Disease Specialists Inc Oklahoma City Oklahoma 73112 —
Gastro One Germantown Tennessee 38138 —
Vanderbilt University Medical Center Nashville Tennessee 37212 —
Tyler Research Institute, LLC Tyler Texas 75701 —
Swedish Medical Center Seattle Washington 98122 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 139 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05347095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 25, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05347095 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →