Crohn´s DiseaseDIVE-23NCT06006039
The Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.
An observational study of Crohn´s Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
Trial summary
Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn´s Disease
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Jun 2023to 1 Nov 2029
- 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
- Adult, Older adult
Study population: The study will be performed in CD patients with postoperative recurrence. Patients will be counselled prior to their routine endoscopy (typically 6-9 months after surgery). In practice, this will be approximately be between one and two weeks before the routine endoscopy. The investigators intend to evaluate 20-30 patients for this study and recruit 40 patients. The reason for this, is that there is a possibility that patients do not have enough inflammation (Rutgeerts ≤i2a) and therefore cannot be included.
Who may be able to join
- Age >/= 18 years;
- Male or non-pregnant, non-lactating females;
- Patients with postoperative recurrence at routine endoscopy 6-24 months following resection, defined by presence of ulcerations (endoscopic Rutgeerts' score >i2a) in the neoterminal ileum;
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements;
- The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Who cannot join
- Any conditions (eg, history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures;
- Any condition in which one of the potential treatments are contraindicated in the opinion of the investigator (eg, cardiac failure class 3-4 according to the New York Heart Association [NYHA], multiple sclerosis, active infections).
- Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
- Currently participating or planning to participate in a study involving an investigational product.
- Active or planned pregnancy during the study.
- Prior diagnosis of dysplasia in the colon (excluding in resected adenomas).
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- History of malignancy in the 3 years prior to randomization except for non-melanoma skin cancer.
- Received a biologic treatment between surgery and first endoscopy.
- Positive Clostridium difficile toxin B in faeces. Patients who test positive can be treated per local practice and still enter the study if no longer than 4 weeks after the screening visit, they test negative for Clostridium difficile toxin B.
- Presence of a stoma without ileocolonic anastomosis or pouch.
- Active perianal abscess or draining fistula
- ALT or AST > 3x the upper limit of normal measured at screening
- Increased risk of bleeding: coagulation disorder, use of anticoagulants and DOACs
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai
Toronto, Ontario, 1X5
Joanne Stempak, joanne.stempak@sinaihealth.ca
Mark Silverberg, dr
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105
Lotte Oldenburg, drs, +31 020 566 9111, l.oldenburg@amsterdamumc.nl
Lotte Oldenburg, drs
About this study
Official title: An Explorative Study to Examine the Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.
Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies. Discovery and development of effective therapies to treat IBDs depend first on a better understanding of the underlying mechanisms, including how proinflammatory cells proliferate unchecked.
It has been established that the cytokine interleukin (IL)-23 plays a pivotal role in IBD pathophysiology and antibodies targeting IL-23 are currently in late stage development for the treatment of both CD and ulcerative colitis (UC). IL-23 is part of the IL-12 family of cytokines (which includes IL-12, IL-27 and IL-35). The p40 subunit is shared among IL-23 and IL-12; the p19 subunit is unique to IL-23. Thus far, the efficacy of selective anti-IL-23 blockade (via anti-p19 antibodies) appears 5-10% better with respect to clinical and endoscopic outcomes than targeting both IL-23 and IL-12 using anti-p40 antibodies. Understanding the effects of IL-23 (and IL-12) in IBDs requires identification of the most relevant immune cells that respond to these cytokines. One likely cell type controlled by the IL-23 pathway are innate lymphoid cells (ILCs). ILC3s (a subset of ILCs) are dominant in healthy intestinal tissue and capable of producing IL-22 which maintain intestinal epithelial homeostasis. Disturbances in the amounts of IL-22 caused by changes in the stimulatory cytokine IL-23 in tissues, may therefore cause inflammatory responses. IL-23 may facilitate the IL-12-induced shift of ILC3s to ILC1s which are contributing to the disease-causing chronic inflammation.
The DIVE 23 project is designed to understand the role of IL-23 in human IBD, in particular CD. It is hypothesized that IL-23R+ cells in the gut, are drivers of chronic inflammation in CD and determine the impact of IL-23 inhibition. To this end the investigators plan to extensively characterize the IL-23-responsive cell populations in inflamed and non-inflamed intestinal tissues of CD patients with postoperative recurrence in order to identify IL-23-responsive immune cell populations that are associated with disease activity. Patients will be treated in routine medical practice with biological agents and will undergo a second ileocolonoscopy 12-16 weeks later to investigate the impact of the different interventions on the mucosal immunology driving CD.
- Conditions
- Crohn´s Disease
- Keywords
- Crohn's Disease, Interleukin-23, Postoperative recurrence
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in concentration and amounts of IL-23 responsive cells in postoperative CD at baseline endoscopy and after 12-16 weeks of routine care treatment with a biological agent.
Single cell analysis
Measured: Week 16
Secondary outcomes (5)
Changes in concentration and amounts in IL-23 pathway cytokines and mediators, at baseline and after 12-16 weeks of biological treatment.
Single cell analysis
Measured: Week 16
Change in modified Rutgeerts' score at baseline endoscopy and follow-up endoscopy (12-16 weeks after biological treatment)
Endoscopic outcome measurement
Measured: Week 16
Change in SES-CD score at baseline endoscopy and follow-up endoscopy (week 12-16, after biological treatment)
Endoscopic outcome measurement
Measured: Week 16
Change in the Harvey-Bradshaw Index (HBI) score at baseline visit and follow-up visits at week 8 and week 12-16.
Clinical outcome measurement
Measured: Week 16
Change in Robarts histopathology index (RHI) score at baseline endoscopy and follow-up endoscopy (week 12-16, after biological treatment).
Histology outcome measurement
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start5 Jun 2023
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn´s DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geert D'Haens, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006039
- Sponsor's protocol ID
- NL82888.018.22
- Acronym
- DIVE-23
- Status last verified
- Nov 2026
- First submitted
- 12 Jul 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study to Examine the Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.
- ClinicalTrials.gov ID
- NCT06006039
- Acronym / sponsor ID
- DIVE-23 / NL82888.018.22
- Conditions
- Crohn´s Disease
- Keywords
- Crohn's Disease, Interleukin-23, Postoperative recurrence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 23 Aug 2023 (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.
Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies. Discovery and development of effective therapies to treat IBDs depend first on a better understanding of the underlying mechanisms, including how proinflammatory cells proliferate unchecked.
It has been established that the cytokine interleukin (IL)-23 plays a pivotal role in IBD pathophysiology and antibodies targeting IL-23 are currently in late stage development for the treatment of both CD and ulcerative colitis (UC). IL-23 is part of the IL-12 family of cytokines (which includes IL-12, IL-27 and IL-35). The p40 subunit is shared among IL-23 and IL-12; the p19 subunit is unique to IL-23. Thus far, the efficacy of selective anti-IL-23 blockade (via anti-p19 antibodies) appears 5-10% better with respect to clinical and endoscopic outcomes than targeting both IL-23 and IL-12 using anti-p40 antibodies. Understanding the effects of IL-23 (and IL-12) in IBDs requires identification of the most relevant immune cells that respond to these cytokines. One likely cell type controlled by the IL-23 pathway are innate lymphoid cells (ILCs). ILC3s (a subset of ILCs) are dominant in healthy intestinal tissue and capable of producing IL-22 which maintain intestinal epithelial homeostasis. Disturbances in the amounts of IL-22 caused by changes in the stimulatory cytokine IL-23 in tissues, may therefore cause inflammatory responses. IL-23 may facilitate the IL-12-induced shift of ILC3s to ILC1s which are contributing to the disease-causing chronic inflammation.
The DIVE 23 project is designed to understand the role of IL-23 in human IBD, in particular CD. It is hypothesized that IL-23R+ cells in the gut, are drivers of chronic inflammation in CD and determine the impact of IL-23 inhibition. To this end the investigators plan to extensively characterize the IL-23-responsive cell populations in inflamed and non-inflamed intestinal tissues of CD patients with postoperative recurrence in order to identify IL-23-responsive immune cell populations that are associated with disease activity. Patients will be treated in routine medical practice with biological agents and will undergo a second ileocolonoscopy 12-16 weeks later to investigate the impact of the different interventions on the mucosal immunology driving CD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will be performed in CD patients with postoperative recurrence. Patients will be counselled prior to their routine endoscopy (typically 6-9 months after surgery). In practice, this will be approximately be between one and two weeks before the routine endoscopy. The investigators intend to evaluate 20-30 patients for this study and recruit 40 patients. The reason for this, is that there is a possibility that patients do not have enough inflammation (Rutgeerts ≤i2a) and therefore cannot be included.
Key inclusion criteria (5 listed)
- Age >/= 18 years;
- Male or non-pregnant, non-lactating females;
- Patients with postoperative recurrence at routine endoscopy 6-24 months following resection, defined by presence of ulcerations (endoscopic Rutgeerts' score >i2a) in the neoterminal ileum;
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements;
- The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Key exclusion criteria (13 listed)
- Any conditions (eg, history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures;
- Any condition in which one of the potential treatments are contraindicated in the opinion of the investigator (eg, cardiac failure class 3-4 according to the New York Heart Association [NYHA], multiple sclerosis, active infections).
- Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
- Currently participating or planning to participate in a study involving an investigational product.
- Active or planned pregnancy during the study.
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
Changes in concentration and amounts of IL-23 responsive cells in postoperative CD at baseline endoscopy and after 12-16 weeks of routine care treatment with a biological agent.
Time frame: Week 16
Single cell analysis
5 secondary outcomes
Changes in concentration and amounts in IL-23 pathway cytokines and mediators, at baseline and after 12-16 weeks of biological treatment.
Time frame: Week 16
Change in modified Rutgeerts' score at baseline endoscopy and follow-up endoscopy (12-16 weeks after biological treatment)
Time frame: Week 16
Change in SES-CD score at baseline endoscopy and follow-up endoscopy (week 12-16, after biological treatment)
Time frame: Week 16
Change in the Harvey-Bradshaw Index (HBI) score at baseline visit and follow-up visits at week 8 and week 12-16.
Time frame: Week 16
Change in Robarts histopathology index (RHI) score at baseline endoscopy and follow-up endoscopy (week 12-16, after biological treatment).
Time frame: Week 16
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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn´s Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Netherlands. 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?
Contact Lotte Oldenburg (020 444 1125, l.oldenburg@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in concentration and amounts of IL-23 responsive cells in postoperative CD at baseline endoscopy and after 12-16 weeks of routine care treatment with a biological agent. (time frame: Week 16). 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 4 Nov 2026.