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NCT06408935

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

A Phase 3b, Single-Arm, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients
Janssen-Cilag Ltd.·Phase 3·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Crohn's Disease
Drug/Device/Intervention
Guselkumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Janssen-Cilag Ltd.
Location
Nahariya,Petah Tikva,Taipei, Israel,Taiwan
Timeline & enrollment
Phase
Phase 3
Start date
Apr 17, 2024
End date
Aug 30, 2028
Enrollment
112 participants
Primary outcome

Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than ()11 in All Intestinal Segments at Week 48

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.

ICD-10 classifications
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06408935
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06408935 through Pure Global AI's free database. This Phase 3 trial is sponsored by Janssen-Cilag Ltd. and is currently Recruiting. The study focuses on Crohn's Disease. Target enrollment is 112 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.