Unravelling Intestinal Fibrosis in Ulcerative Colitis

Recruiting now · Phase 2/Phase 3

Conditions studied: Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Fibroblast Activation Protein Inhibitor

In brief

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

Key facts

Study ID

NCT06604273

Run by

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

People needed

10

Starts

2024-04-03

Expected to finish

2026-04-03

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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