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Unravelling Intestinal Fibrosis in Ulcerative Colitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

Unravelling Intestinal Fibrosis in Ulcerative Colitis

NCT06604273•Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Summary

The main objectives are: (i) to identify candidate fibrotic cellular pathways in UC patients treated with a JAK inhibitor filgotinib), and (ii) to detect and monitor in vivo fibrosis in UC patients using FAPi-PET/CT imaging

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults with confirmed diagnosis of UC - Group 1 criterion: ≥18 years of age regardless of gender
•Group 2 criterion: ≥30 years of age for males and ≥40 years of age for females
•Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2)
•Indication to start treatment with filgotinib
•AND one of the following criteria:
•Active disease confirmed by intestinal ultrasound (BWT \> 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or
•Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)

Exclusion Criteria

•Pregnancy
•Unable to provide informed consent
•Colorectal carcinoma or high-grade dysplasia

Locations (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Key Dates

Start Date

April 3, 2024

Primary Completion Date

October 3, 2025

Completion Date

April 3, 2026

Last Updated

September 19, 2024

Enrollment

ESTIMATED participants

Conditions

Ulcerative Colitis (UC)Inflammatory Bowel Disease (IBD)Fibroblast Activation Protein Inhibitor

Interventions

Fibroblast Activation Protein Inhibitor

DIAGNOSTIC_TEST

Contacts

Dalia A Lartey, MD

CONTACT

+31205668160 d.a.lartey@amsterdamumc.nl

Kelly van Wijnbergen, Msc

CONTACT

+31205668160 k.vanwijnbergen@amsterdamumc.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Unravelling Intestinal Fibrosis in Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

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