Trials / Active Not Recruiting
Active Not RecruitingNCT05347095
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (actual)
- Sponsor
- Janssen-Cilag Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Guselkumab | Guselkumab will be administered subcutaneously/IV infusion. |
| DRUG | Placebo | Matching placebo will be administered subcutaneously/IV infusion. |
Timeline
- Start date
- 2022-09-27
- Primary completion
- 2027-03-25
- Completion
- 2027-03-25
- First posted
- 2022-04-26
- Last updated
- 2026-03-13
Locations
153 sites across 23 countries: United States, Australia, Belgium, Canada, Czechia, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Jordan, Netherlands, Poland, Portugal, Saudi Arabia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05347095. Inclusion in this directory is not an endorsement.