RecruitingPhase 2Phase 3NCT06604273

Unravelling Intestinal Fibrosis in Ulcerative Colitis

Sponsor

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

Enrollment

10 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria7

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)