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NCT07308067Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
109 (actual)
First submitted
15 Dec 2025
Start date
15 Apr 2025
Primary completion date
May 2026
Lead sponsor
University Hospital, Clermont-Ferrand
NCT number
NCT07308067

What you commit to

  • Study type: Observational
  • Participants enrolled: 109
  • From 15 Apr 2025 to the primary completion date, May 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Follow-up shorter than 3 months (except for those discontinuing risankizumab due to side effect or failure)

Other

  • Ulcerative colitis and unclassified colitis

Who the study is looking for

  • Adult Patients (≥ 18 years old) diagnosed with Crohns disease according to ECCO guidelines
  • Initiating risankizumab therapy in routine practice
  • Undergoing IUS procedures before and after risankizumab therapy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amiens University Hospital
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
Clermont-Ferrand University Hospital
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
Grenoble University Hospital
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
Marseille University Hospital
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.