๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease (NCT05347095)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Janssen-Cilag Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (154 Sites)

Showing the first 25 of 154 sites.

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • Yale University โ€” New Haven, Connecticut
  • University of Miami โ€” Miami, Florida
  • Gastroenterology Group Of Naples โ€” Naples, Florida
  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando โ€” Orlando, Florida
  • Kansas University Medical Center โ€” Kansas City, Kansas
  • University of Kentucky Chandler Medical Center โ€” Lexington, Kentucky
  • University of Louisville โ€” Louisville, Kentucky
  • Washington University School Of Medicine โ€” St Louis, Missouri
  • Mount Sinai School of Medicine โ€” New York, New York
  • Digestive Disease Specialists Inc โ€” Oklahoma City, Oklahoma
  • Gastro One โ€” Germantown, Tennessee
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • Tyler Research Institute, LLC โ€” Tyler, Texas
  • Swedish Medical Center โ€” Seattle, Washington
  • Flinders Medical Centre โ€” Adelaide,
  • St Vincent's Hospital - Melbourne โ€” Fitzroy,
  • Liverpool Hospital โ€” Liverpool,
  • Fiona Stanley Hospital โ€” Murdoch,
  • Royal Prince Alfred Hospital โ€” Newtown,
  • Royal Adelaide Hospital โ€” North Terrace,
  • Royal Melbourne Hospital โ€” Parkville,
  • Royal Perth Hospital โ€” Perth,
  • Mater Hospital โ€” South Brisbane,
  • Hopital Erasme โ€” Brussels,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—