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Active Not Recruiting NCT06408935

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

Conditions: Crohn's Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 120
Sponsor: Janssen-Cilag Ltd.

Location: Center for Colitis and Crohns Disease University of California San Francisco California

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.

Eligibility Criteria

Inclusion Criteria: * Has luminal Crohn's disease (CD) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * Has clinically active CD, defined as a baseline CD activity index (CDAI) score greater than or equal to (\>=)220 but \=4, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>=2, based on the unweighted CDAI component of abdominal pain (AP) * Active transmural activity in at least one segment (segmental magnetic resonance index of activity \[MaRIA\] \>= 11) * a. Has demonstrated inadequate response/intolerance to conventional therapy; b. Has previously demonstrated lack of initial response (that is, primary non-responders), responded initially but then lost response with continued therapy (that is, secondary non-responders), or was intolerant to a maximum of 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (that is, janus kinase \[JAK\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents) Exclusion Criteria: * Has complications of Crohn's disease, such as symptomatic strictures or stenoses (unless less than \[\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06408935). StuddyBuddy aggregates publicly available trial information.