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NCT Number: NCT07308067

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amiens university hospital, Amiens, France

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About this study

This will be a prospective, multicenter study (5 centers) based on routine clinical practice, without any additional procedures. Data will be collected from electronic medical records and entered in a pseudonymized manner into the electronic case report form (RedCAP).

The data collected in this study include: demographic data (age, sex); disease-related data (date of diagnosis, disease duration, location, and phenotype); data on risankizumab treatment (start date, dosage, adverse events); clinical data (symptoms); laboratory data (CRP and fecal calprotectin); and radiological data (intestinal ultrasounds). These data will be collected, when available, at treatment initiation with SKYRIZI, and at weeks 4 and 12 as part of routine care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: From enrollment to the end of induction at 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: SKYNETICS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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