RecruitingNCT07308067

Kinetics of Transmural Healing in Patients With Crohns Disease Treated With Risankizumab (SKYRIZI®)


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

100 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can highly alter patients' quality of life and lead to bowel damage due to its transmural pattern. The current guidelines recommend to use treat-to-target strategies to achieve the combination of steroid-free clinical remission and endoscopic remission. However, the implementation of these strategies and endpoints are limited by the need of repeated colonoscopies, which dramatically reduced patients' acceptability and adherence to such a management. The concept of transmural healing has emerged as a promising therapeutic target. It has been associated with longer time spent in steroid-free clinical remission, decreased risk of hospitalization, slower progression of bowel damage and reduced risk of subsequent surgery. Furthermore, recent works suggested that transmural healing could lead to better outcomes, such as prevention of bowel damage progression, than endoscopic remission. Recently, the DEVISE-CD project proposed validated definitions of transmural healing and response (TR50 and TR25) using the modified Clermont score (C-score). Thus, transmural healing will become the next reference target in the near future. Although most data were generated using MRI, intestinal ultrasound (IUS) is an interesting alternative to assess transmural response thanks to its lower cost and high patients' acceptability enabling repeated procedures. IUS is now part of routine practice in day-care units. Recently, Risankizumab, the first in-class anti-IL23 targeting p19 subunit in CD, demonstrated high level of efficacy to achieve and maintain clinical and endoscopic remission. However, no data are hitherto available on the kinetics and the efficacy of risankizumab to achieve transmural healing.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks how well a drug called risankizumab (brand name SKYRIZI) heals the full thickness of the bowel wall in people with Crohn's disease, using a non-invasive ultrasound technique called intestinal ultrasound (IUS) to monitor changes before and after treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of Crohn's disease - You are starting risankizumab treatment as part of your regular care - You are willing to undergo intestinal ultrasound scans before and after starting treatment **You may NOT be eligible if...** - You have ulcerative colitis or unclassified colitis (rather than Crohn's disease) - Your follow-up is expected to be shorter than 3 months (unless stopping risankizumab due to side effects or treatment failure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

Amiens university hospital

Amiens, France

Clermont-Ferrand University hospital

Clermont-Ferrand, France

Grenoble university hospital

Grenoble, France

Marseille University Hospital

Marseille, France

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NCT07308067


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