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

NCT07308067 | Active Not Recruiting

• 1 other identifier: 2025 BUISSON_CF533
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Crohn Disease (CD)

Keywords

Crohn Disease; Transmural response

Outcome Measures

Primary Outcomes (1)

• Transmural response evaluated by IUS at week 4 and 12.

  From enrollment to the end of induction at 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Crohn's disease initiating treatment with risankizumab.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (4)

Amiens university hospital

Amiens, France

Location

Clermont-Ferrand University hospital

Clermont-Ferrand, France

Location

Grenoble university hospital

Grenoble, France

Location

Marseille University Hospital

Marseille, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Anthony Buisson

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: April 15, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (4)