RecruitingNot a traditional drug phaseobservationalRules rewrite

The Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Dise…

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.

Official registry: https://clinicaltrials.gov/study/NCT06006039 · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · enrollment listed as 40

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 40 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Primary outcome (registry wording): 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.

Who it is for (from inclusion criteria)

Ages 18 Years to any
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;

Who the registry excludes

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

Public study contact (from the registry)

Lotte Oldenburg

020 444 1125

l.oldenburg@amsterdamumc.nl

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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

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FAQ about this NCT record

Is NCT06006039 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06006039?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06006039?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary