Unravelling Intestinal Fibrosis in Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2026-04-03

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Half of the study participants will undergo PET CT imaging. Therefore, the interventional study model only applies to half of the study partcipants.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 2

This group undergoes FAPi-PET CT imaging

Group Type EXPERIMENTAL

Fibroblast Activation Protein Inhibitor

Intervention Type DIAGNOSTIC_TEST

PET CT imaging using the fibroblast activation protein inhibitor tracer

Group 1

Does not undergo a FAPi scan

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fibroblast Activation Protein Inhibitor

PET CT imaging using the fibroblast activation protein inhibitor tracer

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FAPi PET CT scan

Eligibility Criteria

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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)