Understanding immune cells in Crohn's disease after surgery

An Explorative Study to Examine the Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.

This study looks at how certain immune cells behave in people with Crohn's disease after surgery to see why the disease comes back for some patients.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 2 sites (Toronto, Ontario and 1 other locations)
• Trial ID: NCT06006039 on ClinicalTrials.gov

What this trial studies

This observational study investigates the role of interleukin-23-responsive immune cell subsets in patients with Crohn's disease who experience postoperative recurrence. It aims to identify the mechanisms behind the unchecked proliferation of proinflammatory cells that contribute to the disease's recurrence after surgical intervention. By analyzing patients who show signs of recurrence during routine endoscopy, the study seeks to enhance the understanding of Crohn's disease pathophysiology and inform future therapeutic strategies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of postoperative recurrence of Crohn's disease as evidenced by endoscopic findings.

Not a fit: Patients with conditions that may interfere with compliance or those for whom potential treatments are contraindicated may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for Crohn's disease, potentially reducing postoperative recurrence rates.

How similar studies have performed: While the role of IL-23 in Crohn's disease is established, this specific approach to understanding postoperative recurrence is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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

Where this trial is running

Toronto, Ontario and 1 other locations

• Mount Sinai — Toronto, Ontario, Canada (Recruiting)
• Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Lotte Oldenburg

Conditions Crohn´s Disease; Crohn's Disease; Interleukin-23; Postoperative recurrence