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Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients - Trial NCT06408935

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.

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NCT06408935
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06408935
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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

Study Focus

Crohn's Disease

Guselkumab

Interventional

drug

Sponsor & Location

Janssen-Cilag Ltd.

Nahariya,Petah Tikva,Taipei, Israel,Taiwan

Timeline & Enrollment

Phase 3

Apr 17, 2024

Aug 30, 2028

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, unspecified
Other Crohn disease
Crohn disease of large intestine
Crohn disease [regional enteritis]
Crohn disease of small intestine

Data Source

ClinicalTrials.gov

NCT06408935

Non-Device Trial