ACTIVE_NOT_RECRUITING

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

Conditions

Fistulizing Crohns Disease Perianal Crohns Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-09-27

Study Completion:2027-03-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05347095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months * Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results * Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)	* Has a very severe luminal disease activity * History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus * Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation * Any medical contraindications preventing study participation * Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease

Inclusion Criteria

Exclusion Criteria

* Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
* Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
* Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)

* Has a very severe luminal disease activity
* History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
* Any medical contraindications preventing study participation
* Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease

Contacts and Locations

Principal Investigator

Janssen-Cilag Ltd. Clinical Trial

STUDY_DIRECTOR

Janssen-Cilag Ltd.

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Yale University

New Haven, Connecticut, 06510

United States

University of Miami

Miami, Florida, 33136

United States

Gastroenterology Group Of Naples

Naples, Florida, 34102

United States

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida, 32804

United States

Kansas University Medical Center

Kansas City, Kansas, 66160

United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Washington University School Of Medicine

St Louis, Missouri, 63110

United States

Mount Sinai School of Medicine

New York, New York, 10029

United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112

United States

Gastro One

Germantown, Tennessee, 38138

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

United States

Tyler Research Institute, LLC

Tyler, Texas, 75701

United States

Swedish Medical Center

Seattle, Washington, 98122

United States

Collaborators and Investigators

Sponsor: Janssen-Cilag Ltd.

Janssen-Cilag Ltd. Clinical Trial, STUDY_DIRECTOR, Janssen-Cilag Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-27

Study Completion Date2027-03-25

Study Record Updates

Study Start Date2022-09-27

Study Completion Date2027-03-25

Terms related to this study

Additional Relevant MeSH Terms

Fistulizing Crohns Disease
Perianal Crohns Disease