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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Unravelling Intestinal Fibrosis in Ulcerative Colitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - Pregnancy - Unable to provide willing to sign a consent form - Colorectal carcinoma or high-grade dysplasia Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Fibroblast Activation Protein Inhibitor

PET CT imaging using the fibroblast activation protein inhibitor tracer

Locations (1)

Amsterdam UMC
Amsterdam, North Holland, Netherlands