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

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.

Conditions

Fistulizing Crohns Disease, Perianal Crohns Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Fistulizing Crohns Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Miami

University of Miami, Miami, Florida, United States, 33136

Naples

Gastroenterology Group Of Naples, Naples, Florida, United States, 34102

Orlando

AdventHealth Medical Group Blood & Marrow Transplant at Orlando, Orlando, Florida, United States, 32804

Kansas City

Kansas University Medical Center, Kansas City, Kansas, United States, 66160

Lexington

University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States, 40536

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Saint Louis

Washington University School Of Medicine, Saint Louis, Missouri, United States, 63110

New York

Mount Sinai School of Medicine, New York, New York, United States, 10029

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen-Cilag Ltd.,

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

Study Record Dates

2027-05-17