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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2022-09-27 |
| Est. Completion | 2027-03-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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.
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