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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: Active Phase 3 study of Fistulizing Crohns Disease and Perianal Crohns Disease, sponsored by Janssen-Cilag.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings \[occurring spontaneously or after gentle finger compression\] and absence of collections greater than (\>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a b
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 |
What the registry record for NCT05347095 still lists
NCT05347095 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05347095's enrollment target sits among peer trials
288 1175th of 2000 higher than 819 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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