Crohn Disease (CD)SKYNETICSNCT07308067
Kinetics of Transmural Healing in Patients With Crohns Disease Treated With Risankizumab (SKYRIZI®)
An observational study of Crohn Disease (CD), run by University Hospital, Clermont-Ferrand at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- How many people
- 109 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Apr 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Crohn's disease initiating treatment with risankizumab.
Who may be able to join
- 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
Who cannot join
- Ulcerative colitis and unclassified colitis
- Follow-up shorter than 3 months (except for those discontinuing risankizumab due to side effect or failure)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Amiens university hospital
Amiens
Clermont-Ferrand University hospital
Clermont-Ferrand
Grenoble university hospital
Grenoble
Marseille University Hospital
Marseille
About this study
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.
Read the detailed description
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.
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn Disease, Transmural response
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Transmural response evaluated by IUS at week 4 and 12.
Measured: From enrollment to the end of induction at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Apr 2025
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Buisson, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308067
- Sponsor's protocol ID
- 2025 BUISSON_CF533
- Acronym
- SKYNETICS
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Transmural Healing in Patients With Crohns Disease Treated With Risankizumab (SKYRIZI®)
- ClinicalTrials.gov ID
- NCT07308067
- Acronym / sponsor ID
- SKYNETICS / 2025 BUISSON_CF533
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn Disease, Transmural response
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Crohn's disease initiating treatment with risankizumab.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Ulcerative colitis and unclassified colitis
- Follow-up shorter than 3 months (except for those discontinuing risankizumab due to side effect or failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transmural response evaluated by IUS at week 4 and 12.
Time frame: From enrollment to the end of induction at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Buisson principal investigator
University Hospital, Clermont-Ferrand
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD), run by University Hospital, Clermont-Ferrand at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transmural response evaluated by IUS at week 4 and 12. (time frame: From enrollment to the end of induction at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.