Unravelling Intestinal Fibrosis in Ulcerative Colitis
Recruiting · NCT06604273 · Interventional (participants receive a specific treatment) · Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
View the official record on ClinicalTrials.gov →Interventions studied
Fibroblast Activation Protein Inhibitor
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Amsterdam UMC - Amsterdam, North Holland, Netherlands