Trials / Recruiting
RecruitingNCT06408935
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- Sponsor
- Janssen-Cilag Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Guselkumab | Guselkumab will be administered IV and SC. |
Timeline
- Start date
- 2024-04-17
- Primary completion
- 2027-06-08
- Completion
- 2028-03-06
- First posted
- 2024-05-10
- Last updated
- 2026-04-13
Locations
84 sites across 14 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Poland, Slovakia, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06408935. Inclusion in this directory is not an endorsement.