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Unravelling Intestinal Fibrosis in Ulcerative Colitis

ConditionsUlcerative Colitis (UC)Inflammatory Bowel Disease (IBD)Fibroblast Activation Protein Inhibitor
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Unable to provide informed consent

Colorectal carcinoma or high-grade dysplasia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fibroblast Activation Protein Inhibitor

    Diagnostic test

    PET CT imaging using the fibroblast activation protein inhibitor tracer

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Group 2Experimental treatment 1 intervention
Group B: Group 1No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Candidate fibrotic cellular pathways

Identification of candidate fibrotic cellular pathways using single cell pathway analysis and mucosal biopsies from UC patients before and at week 24 weeks after treatment initiation with filgotinib.

Time frame
From enrollment to end of study participation at 24 weeks

Secondary outcomes

1

68Ga-FAPi-PET/CT imaging feasibility

Feasilibility 68Ga-FAPi-PET/CT imaging as biomarker to monitor in vivo fibrosis in UC. By detection of in vivo intestinal fibrosis by means of measuring 68Ga-FAPi uptake, both visually as semi-quantitatively, in UC patients using FAPi-PET/CT imaging at baseline and 24 weeks after treatment initiation with filgotinib.

Time frame
From enrollment to end of study participation at 24 weeks
2

Correspondance 68Ga-FAPi uptake and STAT expression

To determine to what extent 68Ga-FAPi bowel uptake in UC patients corresponds to (phospohorylated and total) STAT gene and protein (i.e. down-stream JAK targets) expression

Time frame
From enrollment to end of study participation at 24 weeks
3

Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters

To determine to what extent 68Ga-FAPi bowel uptake in UC patients corresponds to clinical and endoscopic changes after 24 weeks of treatment with filgotinib

Time frame
From enrollment to end of study participation at 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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